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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Procedure: goal directed anaesthesia

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection fraction	Left ventricular ejection fraction measured by TEE	5 minutes after installation of pneumoperitoneum
Ejection fraction	Left ventricular ejection fraction measured by TEE	30 minutes after installation of pneumoperitoneum
Ejection fraction	Left ventricular ejection fraction measured by TEE	60 minutes after installation of pneumoperitoneum

Collaborators and Investigators

• Sponsor: Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: P19.042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No