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)

Phase 4 Completed 127 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2012-11-28
Primary completion: 2014-04-29
Completion: 2014-04-29

Outcome

Met primary endpoint

registry analysis (superiority or other test); Standard NMB vs Deep NMB; p = 0.026; Difference in Least Squares (LS) Means 1.09 (95% CI 0.13 to 2.04); ANCOVA NCT01728584 ↗

registry analysis (superiority or other test); Standard Insufflation Pressure vs Low Insufflation Pressure; p <0.001; Difference in LS Means -3.02 (95% CI -3.99 to -2.05); ANCOVA NCT01728584 ↗

paper Surgeon's score of overall satisfaction with surgical conditions was significantly higher with deep versus moderate NMB indicated by a least-square mean difference of 1.1 points (95% confidence interval 0.1-2.0; P = 0.026). PMID 28251555 ↗

Publications

Results Rosenberg J, Herring WJ, Blobner M, Mulier JP, Rahe-Meyer N, Woo T, Li MK, Grobara P, Assaid CA, Fennema H, Szegedi A. Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study. Adv Ther. 2017 Apr;34(4):925-936. doi: 10.1007/s12325-017-0495-x. Epub 2017 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rocuronium	Other / unclassified	0.45 mg/kg	Intravenous
Background	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Background	Sugammadex	Other / unclassified	4 mg/kg	Intravenous