- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181349
Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed) (INSPIRE)
October 12, 2015 updated by: Merck Sharp & Dohme LLC
Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia.
During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs).
During the second study period, hospital discharge data from the participants will be collected.
The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals.
This is a cross-sectional and retrospective study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
350
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult Portuguese participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents
Description
Inclusion Criteria:
- 18 years of age or older
- Informed consent signed
- Admission for elective surgery
- Administration of nondepolarizing NMBAs during surgery
Exclusion Criteria:
- Admission for emergency surgery
- Reoperation on the same hospital admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
P07535 study participants with a TOF ratio <0.9
Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio <0.9 at PACU arrival.
|
While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.
|
P07535 study participants with a TOF ratio ≥0.9
Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio ≥0.9 at PACU arrival.
|
While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
Time Frame: Upon arrival in the PACU
|
The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed.
Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle.
The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio <0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).
|
Upon arrival in the PACU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents
Time Frame: From start of surgery through PACU arrival
|
Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded.
The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.
|
From start of surgery through PACU arrival
|
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane
Time Frame: From start of surgery through PACU arrival
|
Anesthetic agents administered to participants undergoing surgical procedures were recorded.
The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.
|
From start of surgery through PACU arrival
|
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents
Time Frame: From end of surgery through PACU arrival, an expected average of 10 minutes
|
Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded.
The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.
|
From end of surgery through PACU arrival, an expected average of 10 minutes
|
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events
Time Frame: From end of surgery through hospital discharge, an expected average of 6 days
|
From end of surgery through hospital discharge, an expected average of 6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
July 23, 2010
First Submitted That Met QC Criteria
August 12, 2010
First Posted (Estimate)
August 13, 2010
Study Record Updates
Last Update Posted (Estimate)
October 14, 2015
Last Update Submitted That Met QC Criteria
October 12, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P07535
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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