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OpenTrials
Completed

NCT Number: NCT04076709

Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

goal directed anaesthesia

Procedure

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

Primary outcomes

  1. Blood pressure

    Time frame: 30 minutes after installation of pneumoperitoneum

    Mean arterial pressure

Secondary outcomes

  1. Blood pressure

    Time frame: 5 minutes after installation of pneumoperitoneum

    Mean arterial pressure

  2. Blood pressure

    Time frame: 60 minutes after installation of pneumoperitoneum

    Mean arterial pressure

  3. Cardiac output

    Time frame: 5 minutes after installation of pneumoperitoneum

    Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis

  4. Cardiac output

    Time frame: 30 minutes after installation of pneumoperitoneum

    Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis

  5. Cardiac output

    Time frame: 60 minutes after installation of pneumoperitoneum

    Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis

Other outcomes

  1. Ejection fraction

    Time frame: 5 minutes after installation of pneumoperitoneum

    Left ventricular ejection fraction measured by TEE

  2. Ejection fraction

    Time frame: 30 minutes after installation of pneumoperitoneum

    Left ventricular ejection fraction measured by TEE

  3. Ejection fraction

    Time frame: 60 minutes after installation of pneumoperitoneum

    Left ventricular ejection fraction measured by TEE

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: RELAX-LAP

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2019
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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