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

Completed

Conditions: obesitas
perioperative surgical conditions

Registration Number: NL-OMON44073

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

ASA 1-3,
18 years or older;
BMI > 34 kg/m2;
ability to give informed consent; 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Surgical conditions, with as main research question Does a deep surgical block<br /><br>indeed improve surgical conditions in case of laparoscopic surgery in morbidly<br /><br>obese patients for bariatric surgery? The surgical condition will be<br /><br>determined from a surgical rating condition scale, the Leiden Surgical rating<br /><br>Scale. This is a 5-point ordinal scale ranging from 1 = poor condition to 5 =<br /><br>optimal surgical conditions. The surgeon will score the condition at 15 min<br /><br>intervals. At the time of scoring also the intra-abdominal pressure will be<br /><br>monitored.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end-points include:<br /><br>(1) The hemodynamics during surgery with the main research question Does a<br /><br>deep neuromuscular block coincide with improved hemodynamics during surgery and<br /><br>less postoperative pain?<br /><br>(2) Cardiorespiratory conditions in the post-anesthesia care unit, with the<br /><br>main research question What is the effect of reversal with Sugammadex of a<br /><br>deep surgical muscle block on postoperative breathing activity as measured by<br /><br>respiratory rate and saturation (3) Pain and sedation in the post-anesthesia<br /><br>care unit, with the main research question Does a deep block coincide with<br /><br>less pain compared to a moderate block in the recovery period? and<br /><br>(4) The Postoperative Quality of Recovery Scale (PQRS), with the main question<br /><br>Irrespective of depth of the neuromuscular block during surgery, is the<br /><br>quality of recovery similar in patients that were reversed with sugammadex.</p><br>