A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)
17 september 2018 bijgewerkt door: Merck Sharp & Dohme LLC
Randomized, Controlled, Parallel-Group, Double-Blind Trial to Compare the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures Using a 2x2 Factorial Design in Patients Undergoing Laparoscopic Cholecystectomy (Protocol No. MK-8616-076-03 Also Known as SCH 900616, P07982)
The purpose of this pilot study is to compare the use of deep or standard neuromuscular blockade (NMB) in combination with low or standard insufflation pressure in participants undergoing a surgical procedure, laparoscopic cholecystectomy.
Insufflation refers to the injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow visualization of and access to the surgical field.
The primary hypothesis of the study is that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical conditions as compared to standard NMB.
The in-patient surgery is performed on Day 1 and the participant remains hospitalized for at least 48 hours following the surgery (or at least 24 hours following the surgery, if local practice does not allow 48 hours of hospitalization post surgery).
On Day 8, a follow-up visit/contact including all participants occurs.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a "rescue intervention"), if surgeon considered surgical conditions to be unacceptable.
This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mmHg.
If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mmHg.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
127
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
- Scheduled to undergo an elective in-patient laparoscopic cholecystectomy procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil
- Eligible to undergo rocuronium-induced NMB for endotracheal intubation and maintenance of NMB
- Will recover in the post-anesthesia care unit (PACU) and remain in the hospital for at least 48 hours following the surgical procedure (or at least 24 hours following the surgical procedure, if local practice does not allow 48 hours of hospitalization post surgery)
- Body mass index (BMI) ≤35
- Willing and able to adhere to visit schedules including all required study assessments on Day 3 through 8 (daily pain and medication diary entry)
- For sexually active female participants of child-bearing potential - able to use a medically accepted method of contraception through 7 days after receiving protocol-specified medication
Exclusion criteria:
- Neuromuscular disorders that may affect NMB and/or trial assessments
- Lifetime history of previous abdominal surgery, including laparotomies, Cesarean section, laparoscopic procedures or diagnostic laparoscopies
- Substance abuse or dependence (excluding nicotine) within the past 6 months
- History of a chronic pain condition (requiring continuous/daily pain medication prior to surgery)
- For female participants - lifetime history of a Cesarean section, or has given birth to one or more children within the last year, or is currently pregnant or has the intention to become pregnant between randomization and pregnancy follow-up contact ≥30 days after administration of trial treatments (rocuronium, sugammadex)
- Evidence of acute cholecystitis
- Dialysis-dependency or suspected of having severe renal insufficiency
- Significant hepatic dysfunction that would prevent participation in the trial
- History of or family history of malignant hyperthermia
- Allergy to trial treatments (rocuronium or sugammadex) or their excipients, to opioids/opiates, or other medication used during general anesthesia
- Received or is planned to receive toremifene or fusidic acid within 24 hours before or after receiving rocuronium or sugammadex
- Expected transfer to an Intensive Care Unit after surgery
- Any clinically significant condition or situation, other than the reason for the cholecystectomy that would interfere with the trial evaluations or optimal participation in the trial
- Used any investigational drugs within 30 days of randomization
- Participated in any other clinical trial within 30 days of signing the informed consent form of the current trial
- Participated in any other clinical trial involving any personnel of the investigational or Sponsor staff directly involved with this trial
- Is a family member of any personnel of the investigational or Sponsor staff directly involved with this trial
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Standard NMB and Standard Insufflation Pressure
Treatment condition for this arm is Standard NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
Andere namen:
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
Andere namen:
|
|
Experimenteel: Standard NMB and Low Insufflation Pressure
Treatment condition for this arm is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
Andere namen:
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
Andere namen:
|
|
Experimenteel: Deep NMB and Standard Insufflation Pressure
Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
Andere namen:
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
Andere namen:
|
|
Experimenteel: Deep NMB and Low Insufflation Pressure
Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
Andere namen:
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)
Tijdsspanne: End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): "How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?"
If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention).
The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
|
End of surgery (Day 1)
|
|
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm
Tijdsspanne: End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): "How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?"
If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention).
The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
|
End of surgery (Day 1)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)
Tijdsspanne: Up to 24 hours after administration of sugammadex on Day 1
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.
|
Up to 24 hours after administration of sugammadex on Day 1
|
|
Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm
Tijdsspanne: Up to 24 hours after administration of sugammadex on Day 1
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.
|
Up to 24 hours after administration of sugammadex on Day 1
|
|
Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)
Tijdsspanne: End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): "How satisfied were you overall with the visual field during the surgery you just performed?"
If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
|
End of surgery (Day 1)
|
|
Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)
Tijdsspanne: End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): "How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"
|
End of surgery (Day 1)
|
|
Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)
Tijdsspanne: End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): "How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"
|
End of surgery (Day 1)
|
|
Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)
Tijdsspanne: During surgery, approximate duration of 1-2 hours (Day 1)
|
At the end of the procedure the surgeon responds to the following question: "How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?"
|
During surgery, approximate duration of 1-2 hours (Day 1)
|
|
Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)
Tijdsspanne: End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): "How did the patient movements described above disrupt your surgical performance?"
This refers to participant movements during surgery.
|
End of surgery (Day 1)
|
|
Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm
Tijdsspanne: During surgery, approximate duration of 1-2 hours (Day 1)
|
During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a "rescue intervention"), if surgeon considered surgical conditions to be unacceptable.
This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg.
If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg.
The unblinded anesthetist recorded any rescue actions performed.
This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.
|
During surgery, approximate duration of 1-2 hours (Day 1)
|
|
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm
Tijdsspanne: Days 2 to 8
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
This measure summarizes the assessment of overall pain at rest for the study days following the surgery.
|
Days 2 to 8
|
|
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm
Tijdsspanne: Days 2 to 8
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
This measure summarizes the assessment of provoked pain for the study days following the surgery.
|
Days 2 to 8
|
|
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm
Tijdsspanne: Days 2 to 8
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
This measure summarizes the assessment of shoulder pain for the study days following the surgery.
|
Days 2 to 8
|
|
Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm
Tijdsspanne: Up to Day 8
|
Post operative use of pain/analgesic medication by participant through Day 8 was recorded.
|
Up to Day 8
|
Medewerkers en onderzoekers
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Sponsor
Publicaties en nuttige links
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
28 november 2012
Primaire voltooiing (Werkelijk)
29 april 2014
Studie voltooiing (Werkelijk)
29 april 2014
Studieregistratiedata
Eerst ingediend
16 oktober 2012
Eerst ingediend dat voldeed aan de QC-criteria
13 november 2012
Eerst geplaatst (Schatting)
20 november 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 oktober 2018
Laatste update ingediend die voldeed aan QC-criteria
17 september 2018
Laatst geverifieerd
1 september 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P07982
- MK-8616-076 (Andere identificatie: Merck)
- 2012-001886-33 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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