The Laparotomy Study

Phase 4

Completed

• Conditions: Gastrointestinal Cancer

• Registration Number: NCT02140593
• Lead Sponsor: Herlev Hospital

Brief Summary

The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-16
• Study Start: 2014-09
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Results First Submitted: 2017-01-10
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Results First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Patients > 18 years old
• Elective open upper abdominal surgery
• Can read and understand Danish
• Informed consent

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
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Rating Score	After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes	The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)

Secondary Outcome Measures

Name	Time	Method
The Surgical Rating Score During Fascial Closure	Immediatly after fascial closure	After last suture of fascial closure surgical conditions are rated on a 5 point scale

Trial Locations

Locations (1)

Aarhus University Hospital Nørrebrogade; 🇩🇰 Aarhus, Denmark