Muscle relaxation during open abdominal surgery-can the surgiceon have better operating conditions?(The laparotomy study)

Phase 1

• Conditions: The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.; MedDRA version: 17.0Level: LLTClassification code 10023697Term: Laparotomy & drainageSystem Organ Class: 100000004865; MedDRA version: 17.0Level: LLTClassification code 10051777Term: Staging laparotomySystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-001155-22-DK
• Lead Sponsor: Mona Ring Gätke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-21
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

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

Inclusion Criteria

Patients > 18 years old
Elective open upper abdominal surgery: Whipple, gastrectomy, gastric resection, liver resection and laparotomies due to bile obstruction i.e. hepaticojejunostomy (not cholecystectomy)
Can read and understand Danish
Informed consent

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Known allergy to rocuronium or sugammadex
Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis
Neuromuscular disease that may interfere with neuromuscular data
Abdominal mesh with size larger than 5*5 cm
Lactating or pregnant

Study & Design

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