The Laparotomy Study

Gastrointestinal Cancer Clinical Trial

Official title:

Muscle Relaxation During Open Upper Abdominal Surgery - Can the Surgical Conditions be Optimized?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140593
• Other study ID #: Lap2014NMB
• Secondary ID: 2014-001155-22
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2014
• Last updated: October 31, 2016
• Start date: September 2014

Study information

• Verified date: October 2016
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Drug:
• Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).

• Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital Nørrebrogade	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical rating score	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)	After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes	No
Secondary	The surgical rating score during fascial closure	After last suture of fascial closure surgical conditions are rated on a 5 point scale	Immediatly after fascial closure	No