Optimization of surgical condition during laparoscopic removal of the gallbladder

Phase 1

• Conditions: Surgical conditions during laparoscopic cholecystectomy; MedDRA version: 14.1Level: PTClassification code 10008611Term: CholecystectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-005502-29-DK
• Lead Sponsor: Mona R Gätke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-09
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Patients older than 18 years
Scheduled for elective laparoscopic cholecystectomy
Can read and understand Danish
Women must be post-menopaursal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Known allergy to medications that are included in the project
Presence of severe renal disease
Presence of neuromuscular disease
Presence of reduced liver function
Nursing or pregnant
Indication for crash induction
For fertile women: Missing negative pregnant-test

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients older than 18 years, who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg;Secondary Objective: To compare the pain level after surgery with two degrees of neuromscular blockade;Primary end point(s): The surgical conditions assessed at the time during surgery, when they were poorest (4-stage scale);Timepoint(s) of evaluation of this end point: At the end of surger