A Randomized Parallel Design Study to Compare the Impact of Intraoperative Deep Neuromuscular Blockade on Intraoperative NOL-guided Opioid Requirement and Postoperative Early Outcomes in Laparoscopic Colorectal Surgeries
Sponsor study identifier
interventional
100
1 country
1
Study Start
May 30, 2019
Actual (reported)Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the present study is to answer the question whether deep neuromuscular blockade has a clinically significant impact on intra and postoperative pain, opioid requirement and anesthesia related outcomes and side effects for the early phase of recovery (24hs) after colorectal laparoscopic surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 4, 2019
Actual (reported)April 10, 2019
Actual (reported)May 30, 2019
Actual (reported)July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Total intra-operative remifentanil consumption during surgery in mcg/kg/h
To compare total intra-operative remifentanil consumption (in mcg per hour from T0 incision until Tend = start dressing) during anesthesia for laparoscopic colorectal surgery between two groups: Group "D" for Deep muscle relaxation and group "M" for Moderate muscle relaxation
Intra-operative (from T0 incision until Tend = start dressing)
Number of IV boluses and increases of remifentanil infusion, number, no unit
Intra-operative (from T0 incision until Tend = start dressing)
Number of times NOL index passes over the threshold of 25, number, no unit
Intra-operative (from T0 incision until Tend = start dressing)
Area Under the Curve (AUCs) whenever the NOL is above 25, no unit
Intra-operative (from T0 incision until Tend = start dressing)
Total intraoperative time from T0 until Tend with NOL above 25 in minutes
Intra-operative (from T0 incision until Tend = start dressing)
Intraoperative level of intra-abdominal pressure (IAP) in mmHg
Intra-operative (from T0 incision until Tend = start dressing)
A bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia. Rocuronium IV bolus guided by TOF that must remain between 1-3 / 4 during surgery.
A bolus of 0.4 mg/kg of IV rocuronium will be given at the induction of the anesthesia. Bolus of rocuronium 0.1 mg/kg IV will be given during surgery to keep the TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes).
Bolus of rocuronium 0.1 mg/kg at the discretion of anesthetist to keep the TOF between 1-3 out of 4 during surgery
Bolus of rocuronium 0.1 mg/kg IV will be given during surgery for a TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes).
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal
Montreal East, Quebec, H1T2M4, Canada
Morisson L, Harkouk H, Othenin-Girard A, Oulehri W, Laferriere-Langlois P, Belanger ME, Idrissi M, Godin N, Verdonck O, Fortier LP, Poirier M, Henri M, Latulippe JF, Tremblay JF, Trepanier JS, Bendavid Y, Raft J, Richebe P. Impact of deep neuromuscular blockade on intraoperative NOL-guided remifentanil requirement during desflurane anesthesia in laparoscopic colorectal surgeries: A randomised controlled trial. J Clin Anesth. 2024 Dec;99:111659. doi: 10.1016/j.jclinane.2024.111659. Epub 2024 Oct 23.
Philippe PR Richebé, MD PhD
CIUSSS Est de l'île de Montréal
First Submitted
March 4, 2019
First Posted
April 10, 2019
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Study Start
May 30, 2019
Actual (reported)Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 5, 2022
Record last verified: 2022-04
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