- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724932
Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
A Multi-center, Randomized, Parallel-group, Comparative, Active-controlled, Safety-assessor Blinded Trial in Adult Subjects Comparing the Efficacy and Safety of Sugammadex (SCH 900616, ORG 25969) Administered at 1-2 PTC With Neostigmine Administered at Reappearance of T2 in Subjects Undergoing Laparoscopic Cholecystectomy or Appendectomy Under Propofol Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In those surgical procedures where a neuromuscular block is desired for intubation and/or avoid unwanted muscular activity, anesthesiologists may use a more profound NMB until the end of surgery, e.g. in open abdominal procedures or during laparoscopic procedures in order to improve surgical conditions. Reversal with sugammadex at a dose of 4.0 mg.kg-1 at 1-2 PTC after an intubation dose of 0.6 mg.kg-1 or maintenance dosing rocuronium has been found to be both safe and efficacious in previous clinical trials but has never been investigated exclusively in participants undergoing laparoscopic cholecystectomy or appendectomy.
With sugammadex profound muscle relaxation may now be provided right up to the end of the surgical procedure. This may lead to improved Patient Outcomes, such as improvement in the time from end of surgery to the discharge to the PACU. In this multi-center, randomized, parallel-group, active-controlled, safety-assessor blinded trial such benefits will be further investigated.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants of American Society of Anesthesiologists class 1-3
- Participants of age above or equal to the age of 18 years
- Participants who are scheduled to undergo a laparoscopic cholecystectomy or appendectomy under general anesthesia requiring neuromuscular relaxation with rocuronium, and if applicable, maintenance of neuromuscular blockade
- Participants who have given written informed consent
Exclusion Criteria:
- Participants in whom a difficult intubation because of anatomical malformations is expected
- Participants known or suspected to have neuromuscular disorders affecting NMB
- Participants known or suspected to have a significant renal dysfunction
- Participants known or suspected to have a severe hepatic dysfunction
- Participants known or suspected to have (family) history of malignant hyperthermia
- Participants known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
- Participants in whom the use of neostigmine and/or atropine is contraindicated
- Female participants who are pregnant (pregnancy will be excluded for women both from medical history and by a human chorionic gonadotropin (hCG) test within 24h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy)
- Female participants who are breast-feeding
- Participants who participated in another clinical trial not pre-approved by the sponsor, within 30 days of entering into trial 19.4.318 (P05699)
- Participants who have already participated in a sugammadex trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sugammadex
4.0 mg.kg-1 sugammadex at 1-2 PTC
|
Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium.
After this dose, maintenance doses of 0.1-0.2
mg.kg-1 rocuronium may be given.
Other Names:
After the last dose of rocuronium has been administered, participants will receive, according to the randomization, a single bolus dose of 4.0 mg.kg-1 sugammadex at 1-2 PTC.
Other Names:
|
Experimental: Neostigmine
50 µg.kg-1
neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
|
Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium.
After this dose, maintenance doses of 0.1-0.2
mg.kg-1 rocuronium may be given.
Other Names:
After the last dose of rocuronium has been administered, participants will receive, according to the randomization, 50 μg.kg-1
neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.
Other Names:
After the last dose of rocuronium has been administered, participants will receive, according to randomization, 10 μg.kg-1 atropine (with neostigmine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
Time Frame: From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)
|
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation.
The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB).
In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB.
A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
|
From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7
Time Frame: From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)
|
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation.
The T4/T1 Ratio (expressed as a decimal of up to 1.0).
A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
|
From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)
|
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8
Time Frame: From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)
|
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation.
The T4/T1 Ratio (expressed as a decimal of up to 1.0).
A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
|
From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)
|
Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs
Time Frame: From signing of informed consent to end of trial (7 days after surgery)
|
An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect. Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration. |
From signing of informed consent to end of trial (7 days after surgery)
|
Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs
Time Frame: From signing of informed consent to end of trial (7 days after surgery)
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product.
Participants were monitored for occurrence AEs for up to 7 days after last dose IMP.
Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration.
Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.
|
From signing of informed consent to end of trial (7 days after surgery)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6
Time Frame: From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)
|
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation.
The T4/T1 Ratio (expressed as a decimal of up to 1.0).
Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.
|
From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)
|
Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9
Time Frame: From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)
|
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle.
T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation.
The T4/T1 Ratio (expressed as a decimal of up to 1.0).
A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.
|
From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)
|
Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group
Time Frame: From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)
|
The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation.
Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement.
1-2 PTC was the target depth of NMB at which sugammadex was to be administered.
|
From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)
|
Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group
Time Frame: From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)
|
The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation.
Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.
|
From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)
|
Mean Systolic Blood Pressure
Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)
|
Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).
|
At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)
|
Mean Diastolic Blood Pressure
Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)
|
Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).
|
At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)
|
Mean Heart Rate
Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)
|
Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).
|
At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)
|
Number of Participants Who Had Physical Examinations
Time Frame: At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)
|
Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).
|
At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)
|
Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events
Time Frame: From induction of anesthesia to recovery from NMB (up to ~3 hours)
|
Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.
|
From induction of anesthesia to recovery from NMB (up to ~3 hours)
|
Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)
Time Frame: Up to 30 minutes after IMP administration
|
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle.
T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation.
The T4/T1 Ratio is expressed as a decimal of up to 1.0.
A higher ratio indicates greater recovery from NMB.
A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.
|
Up to 30 minutes after IMP administration
|
Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)
Time Frame: Up to 24 hours after IMP administration
|
Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.
|
Up to 24 hours after IMP administration
|
Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium
Time Frame: Up to 7 days after IMP administration
|
Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.
|
Up to 7 days after IMP administration
|
Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites
Time Frame: Up to PACU discharge (up to ~4.5 hours)
|
The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.
|
Up to PACU discharge (up to ~4.5 hours)
|
Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study
Time Frame: Up to 30 days after IMP administration
|
Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.
|
Up to 30 days after IMP administration
|
Time From Operating Room Admission to Operating Room Discharge Ready
Time Frame: From Operating Room admission to Operating Room discharge ready (up to ~3 hours)
|
The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room.
The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.
|
From Operating Room admission to Operating Room discharge ready (up to ~3 hours)
|
Time From Operating Room Admission to Actual Operating Room Discharge
Time Frame: From Operating Room admission to actual Operating Room discharge (up to ~3 hours)
|
The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room.
The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.
|
From Operating Room admission to actual Operating Room discharge (up to ~3 hours)
|
Time From Operating Room Discharge Ready to Actual Operating Room Discharge
Time Frame: From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)
|
The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.
The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.
|
From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)
|
Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90
Time Frame: From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)
|
The time of IMP administration was defined as the actual time at which IMP administration was started.
|
From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)
|
Time From Start of IMP Administration to Tracheal Extubation
Time Frame: From start of IMP administration to tracheal extubation (up to ~21 minutes)
|
The time of IMP administration was defined as the actual time at which IMP administration was started.
The time of tracheal extubation was defined as the actual time at which the participant was extubated.
|
From start of IMP administration to tracheal extubation (up to ~21 minutes)
|
Time From Start of IMP Administration to Operating Room Discharge Ready
Time Frame: From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)
|
The time of IMP administration was defined as the actual time at which IMP administration was started.
The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.
|
From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)
|
Time From Start of IMP Administration to Actual Operating Room Discharge
Time Frame: From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)
|
The time of IMP administration was defined as the actual time at which IMP administration was started.
The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.
|
From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)
|
Time From Tracheal Extubation to Operating Room Discharge Ready
Time Frame: From tracheal extubation to Operating Room discharge ready (up to ~1 minute)
|
The time of tracheal extubation was defined as the actual time at which the participant was extubated.
The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.
|
From tracheal extubation to Operating Room discharge ready (up to ~1 minute)
|
Time From Tracheal Extubation to Actual Operating Room Discharge
Time Frame: From tracheal extubation to actual OR discharge (up to ~5 minutes)
|
The time of tracheal extubation was defined as the actual time at which the participant was extubated.
The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.
|
From tracheal extubation to actual OR discharge (up to ~5 minutes)
|
Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready
Time Frame: From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)
|
The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.
The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9.
The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU.
The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.
|
From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)
|
Time From Operating Room Discharge Ready to Actual PACU Discharge
Time Frame: From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)
|
The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.
The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.
|
From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)
|
Time From Actual Operating Room Discharge to PACU Discharge Ready
Time Frame: From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)
|
The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.
The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9.
The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU.
The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.
|
From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)
|
Time From Actual Operating Room Discharge to Actual PACU Discharge
Time Frame: From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)
|
The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.
The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.
|
From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)
|
Time From PACU Admit to PACU Discharge Ready
Time Frame: From PACU admit to PACU discharge ready (up to ~25 minutes)
|
The time of PACU admit was defined as the actual time the participant was admitted to the PACU.
The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9.
The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU.
The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.
|
From PACU admit to PACU discharge ready (up to ~25 minutes)
|
Time From PACU Admit to Actual PACU Discharge
Time Frame: From PACU admit to actual PACU discharge (up to ~4.3 hours)
|
The time of PACU admit was defined as the actual time the participant was admitted to the PACU.
The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.
|
From PACU admit to actual PACU discharge (up to ~4.3 hours)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
- Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.
- Suresh D, Carter JA, Whitehead JP, Goldhill DR, Flynn PJ. Cardiovascular changes at antagonism of atracurium. Effects of different doses of premixed neostigmine and glycopyrronium in a ratio of 5:1. Anaesthesia. 1991 Oct;46(10):877-80. doi: 10.1111/j.1365-2044.1991.tb09609.x.
- Caldwell JE. Reversal of residual neuromuscular block with neostigmine at one to four hours after a single intubating dose of vecuronium. Anesth Analg. 1995 Jun;80(6):1168-74. doi: 10.1097/00000539-199506000-00018.
- Irie T, Uekama K. Pharmaceutical applications of cyclodextrins. III. Toxicological issues and safety evaluation. J Pharm Sci. 1997 Feb;86(2):147-62. doi: 10.1021/js960213f.
- Geldner G, Niskanen M, Laurila P, Mizikov V, Hubler M, Beck G, Rietbergen H, Nicolayenko E. A randomised controlled trial comparing sugammadex and neostigmine at different depths of neuromuscular blockade in patients undergoing laparoscopic surgery. Anaesthesia. 2012 Sep;67(9):991-8. doi: 10.1111/j.1365-2044.2012.07197.x. Epub 2012 Jun 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Adjuvants, Anesthesia
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Neuromuscular Agents
- Cholinesterase Inhibitors
- Mydriatics
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Parasympathomimetics
- Bromides
- Rocuronium
- Atropine
- Neostigmine
Other Study ID Numbers
- P05699
- 19.4.318 (Other Identifier: Organon Protocol ID)
- MK-8616-002 (Other Identifier: Merck Protocol ID)
- 2007-007951-14 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Jagiellonian UniversityRecruitingAnesthesia, General | Analgesics, Opioid | Anesthesia, EndotrachealPoland
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Antalya Training and Research HospitalCompletedAnesthesia, General | Anesthesia, Spinal | Umbilical CordTurkey
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Samsung Medical CenterUnknownGeneral Anesthesia | Total Intravenous Anesthesia | Bispectral Index MonitoringKorea, Republic of
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Armed Forces Hospital, PakistanCompletedGeneral Anesthesia | Epidural AnesthesiaPakistan
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Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
Clinical Trials on Rocuronium
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Radboud University Medical CenterMerck Sharp & Dohme LLCUnknown
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Medtronic - MITGCompletedAnesthesia | Neuromuscular BlockadeUnited States
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University of RostockCompletedObservation of Neuromuscular Block | Complication of Ventilation TherapyGermany
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Sheba Medical CenterUnknown
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Pontificia Universidad Catolica de ChileCompletedNeuromuscular Blockade
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Rigshospitalet, DenmarkCompletedA Comparison of Rocuronium 0.3 mg/kg, and 0.9 mg/kg for Induction of Anesthesia in Elderly Patients.Anesthesia | Intubation Complication | Neuromuscular Blockade | Neuromuscular Blockade, ResidualDenmark
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Asan Medical CenterCompletedNeuromuscular BlockadeKorea, Republic of
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Memorial Sloan Kettering Cancer CenterRecruitingProstate CancerUnited States
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SMG-SNU Boramae Medical CenterUnknownSore ThroatKorea, Republic of
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Merck Sharp & Dohme LLCCompleted