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.
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2019
CompletedFirst Posted
Study publicly available on registry
September 3, 2019
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2025
CompletedApril 2, 2025
March 1, 2025
4.6 years
August 21, 2019
March 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Blood pressure
Mean arterial pressure
30 minutes after installation of pneumoperitoneum
Secondary Outcomes (5)
Blood pressure
5 minutes after installation of pneumoperitoneum
Blood pressure
60 minutes after installation of pneumoperitoneum
Cardiac output
5 minutes after installation of pneumoperitoneum
Cardiac output
30 minutes after installation of pneumoperitoneum
Cardiac output
60 minutes after installation of pneumoperitoneum
Other Outcomes (3)
Ejection fraction
5 minutes after installation of pneumoperitoneum
Ejection fraction
30 minutes after installation of pneumoperitoneum
Ejection fraction
60 minutes after installation of pneumoperitoneum
Study Arms (2)
Standard Care
NO INTERVENTIONGoal directed anesthesia
EXPERIMENTALDeep neuromuscular blockade (post tetanic count 1-2 twitches) and nociception guided anaesthesia
Interventions
Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25
Eligibility Criteria
You may qualify if:
- ASA 1-3;
- Scheduled for lower laparoscopic abdominal surgery;
- Ability to give oral and written consent;
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leiden University Medical Center
Leiden, Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 21, 2019
First Posted
September 3, 2019
Study Start
September 1, 2020
Primary Completion
March 26, 2025
Study Completion
March 27, 2025
Last Updated
April 2, 2025
Record last verified: 2025-03