Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Hemodynamic Instability
• Interventions: Procedure: goal directed anaesthesia

• Registration Number: NCT04076709
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2020-09-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-27
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal directed anesthesia	goal directed anaesthesia	Deep neuromuscular blockade (post tetanic count 1-2 twitches) and nociception guided anaesthesia

Primary Outcome Measures

Name	Time	Method
Blood pressure	30 minutes after installation of pneumoperitoneum	Mean arterial pressure

Secondary Outcome Measures

Name	Time	Method
Blood pressure	60 minutes after installation of pneumoperitoneum	Mean arterial pressure
Cardiac output	60 minutes after installation of pneumoperitoneum	Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands