Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery (RELAX-LAP)

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Hemodynamic Instability

Treatments: Procedure: goal directed anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04076709

P19.042

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Standard Care

No Intervention group

Goal directed anesthesia

Experimental group

Description:

Deep neuromuscular blockade (post tetanic count 1-2 twitches) and nociception guided anaesthesia

Treatment:

Procedure: goal directed anaesthesia