Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.

Official Title
-----------------
Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Conditions
-----------------
Surgical Conditions

Intervention / Treatment
-----------------
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III BMI > 34 kg/m2 Elective bariatric surgery. Exclusion Criteria: Known or suspected neuromuscular disorders impairing neuromuscular function Allergies to muscle relaxants, anesthetics or narcotics A(family) history of malignant hyperthermia Women who are or may be pregnant or are currently breast feeding Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: moderate neuromuscular block<br>rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches | Drug: Rocuronium<br> <br> |
| Experimental: deep neuromuscular block<br>rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches | Drug: Rocuronium<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Rating | During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation | The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation). | intraoperative | 
| Pain | pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported. | postoperative, for up to 2 hours | 
| Respiration | Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. The data were averaged per subject and the mean of the mean data are reported. | 2 hours postoperative | 
| Mean Arterial Blood Pressure | Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit. The data will be averaged per subject and the mean of the mean values are reported. | 2 hours postoperative |