The Laparotomy Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastrointestinal Cancer

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard neuromuscular blockade<br>Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo). | Drug: Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).<br> <br> |
| Active Comparator: Deep neuromuscular blockade<br>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. | Drug: 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.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |