CompletedNot Applicable

Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

Netherlands34 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood pressure

Timeframe: 30 minutes after installation of pneumoperitoneum

Trial details

NCT IDNCT04076709

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-26

View on ClinicalTrials.gov More Hemodynamic Instability trials