Effects of Depth of NMB & Insufflation Pressure on Surgical Conditions
Research type
Research Study
Full title
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-8616-076-00 also known as SCH 900616, PO7982)
IRAS ID
123264
Contact name
Martin Shields
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2012-001886-33
Research summary
The purpose of this pilot trial is to investigate the potential benefits of deep neuromuscular blockade for patients, surgeons and anaesthetists. Neuromuscular blockade is the inhibition of a muscular contraction activated by the nervous system. The level of blockade in laparoscopic cholecystectomy (gall bladder) surgery causes temporary, reversible muscle paralysis and low block (muscle paralysis) is standard procedure to allow the surgeon to work. The trial is designed to examine the combination of standard v low insufflation pressure (blowing gas into the body to make more working room for the surgeon) and deep v standard neuromuscular blockade in 120 subjects undergoing laparoscopic (key-hole) surgery to remove the gall bladder. The primary objective of the study is to assess the benefit of deep neuromuscular blockade in surgical conditions when compared to standard neuromuscular blockade. The key secondary objective is to assess whether the use of low insufflation pressure improves the patient's pain score within 24 hours as compared to standard insufflation pressure. Additionally, the study will evaluate the visual field during laparoscopy (as determined by the surgeon) after use of deep neuromuscular blockade compared to standard neuromuscular blockade.
REC name
HSC REC B
REC reference
13/NI/0006
Date of REC Opinion
7 Feb 2013
REC opinion
Further Information Favourable Opinion