Effects of Depth of Neuromuscular Blockade and Insufflation Pressure on Surgical Conditions.

Phase 1

• Conditions: Patients undergoing elective in-patient laparoscopic cholecystectomy procedures under general anesthesia with neuromuscular relaxation and active reversal of neuromuscular blockade.; MedDRA version: 14.1 Level: LLT Classification code 10018061 Term: General anesthesia System Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-001886-33-IT
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-23
• Study Completion: 2014-04-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 127

Inclusion Criteria

Subjects must be: Males/Females = 18 yrs; ASA (American Society of Anesthesiologists) Class 1, 2 or 3; scheduled for laparoscopic cholecystectomy (standard 4-hole) procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil and is expected to undergo rocuronium-induced neuromuscular blockade for endotracheal intubation and require active reversal of neuromuscular blockade.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Subjects with neuromuscular disorders that may affect neuromuscular blockade and/or assessments will be excluded from this study, in addition subjects who cannot meeting general standards for anesthesia trials (inability to intubate, renal/hepatic dysfunction, allergies to general anesthesia medications, malignant hyperthermia, interactions with toremifene/fusidic acid, pregnant patients, previous enrollment in trials or relation to staff) will also be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified