Back to results

The Laparotomy Study

Primary Purpose

Gastrointestinal Cancer

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

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.

About this trial

This is an interventional treatment trial for Gastrointestinal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aarhus University Hospital Nørrebrogade

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard neuromuscular blockade

Deep neuromuscular blockade

Arm Description

Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).

Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.

Outcomes

Primary Outcome Measures

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; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)

Secondary Outcome Measures

The Surgical Rating Score During Fascial Closure

After last suture of fascial closure surgical conditions are rated on a 5 point scale

Full Information

NCT ID

NCT02140593

First Posted

May 13, 2014

Last Updated

March 9, 2017

Sponsor

Herlev Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02140593

Brief Title

The Laparotomy Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herlev Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard neuromuscular blockade

Arm Type

Placebo Comparator

Arm Description

Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).

Arm Title

Deep neuromuscular blockade

Arm Type

Active Comparator

Arm Description

Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

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.

Primary Outcome Measure Information:

Title

Surgical Rating Score

Description

Time Frame

After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes

Secondary Outcome Measure Information:

Title

The Surgical Rating Score During Fascial Closure

Description

After last suture of fascial closure surgical conditions are rated on a 5 point scale

Time Frame

Immediatly after fascial closure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matias V Madsen, MD

Organizational Affiliation

Herlev Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University Hospital Nørrebrogade

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28969327

Citation

Madsen MV, Scheppan S, Mork E, Kissmeyer P, Rosenberg J, Gatke MR. Influence of deep neuromuscular block on the surgeons assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex. Br J Anaesth. 2017 Sep 1;119(3):435-442. doi: 10.1093/bja/aex241.

Results Reference

derived

PubMed Identifier

26441396

Citation

Madsen MV, Scheppan S, Kissmeyer P, Mork E, Rosenberg J, Gatke MR. Neuromuscular blockade for improvement of surgical conditions during laparotomy: protocol for a randomised study. Dan Med J. 2015 Oct;62(10):A5139.

Results Reference

derived

Learn more about this trial

The Laparotomy Study

We'll reach out to this number within 24 hrs