Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Many surgical procedures are performed using the laparoscopic approach. However, insufflation of the abdomen (pneumoperitoneum) has detrimental hemodynamic effects. The investigators intend to investigate the effect of deep neuromuscular block and nociception guided anaesthesia on hemodynamic variables during pneumoperitoneum for lower abdominal laparoscopic surgery.

Official Title
-----------------
The Impact of Neuromuscular Relaxation and Nociception Guided Anaesthesia on Hemodynamic Variables During Lower Abdominal Laparoscopic Surgery: a Strategy Trial.

Conditions
-----------------
Hemodynamic Instability

Intervention / Treatment
-----------------
* Procedure: goal directed anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-3; Scheduled for lower laparoscopic abdominal surgery; Ability to give oral and written consent; 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; Preexisting cardiac disease (any); Untreated or uncontrolled hypertension; COPD gold 3 or higher Preexistent esophageal pathology (stricture, tumor, diverticulum) Any increased risk factor for upper gastro intestinal tract bleed: History of GI surgery; History of GI bleed; Esophageal varices; Gastric or esophageal inflammation; Severe thrombocytopenia (less than 50k) or severely elevated INR (>4).

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br> | |
| Experimental: Goal directed anesthesia<br>Deep neuromuscular blockade (post tetanic count 1-2 twitches) and nociception guided anaesthesia | Procedure: goal directed anaesthesia<br>* Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Mean arterial pressure | 30 minutes after installation of pneumoperitoneum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Mean arterial pressure | 5 minutes after installation of pneumoperitoneum | 
| Blood pressure | Mean arterial pressure | 60 minutes after installation of pneumoperitoneum | 
| Cardiac output | Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis | 5 minutes after installation of pneumoperitoneum | 
| Cardiac output | Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis | 30 minutes after installation of pneumoperitoneum | 
| Cardiac output | Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis | 60 minutes after installation of pneumoperitoneum |