Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04076709

Acronym

RELAX-LAP

Enrollment

Registered

2019-09-03

Start date

2020-09-01

Completion date

2025-03-27

Last updated

2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

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.

Interventions

PROCEDUREgoal directed anaesthesia

Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure	30 minutes after installation of pneumoperitoneum	Mean arterial pressure

Secondary

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

Other

Measure	Time frame	Description
Ejection fraction	5 minutes after installation of pneumoperitoneum	Left ventricular ejection fraction measured by TEE

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026