Status:

COMPLETED

Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

Lead Sponsor:

Leiden University Medical Center

Conditions:

Hemodynamic Instability

Eligibility:

All Genders

18+ years

Phase:

NA

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 investi...

Eligibility Criteria

Inclusion

  • ASA 1-3;
  • Scheduled for lower laparoscopic abdominal surgery;
  • Ability to give oral and written consent;

Exclusion

  • 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).

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 27 2025

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT04076709

Start Date

September 1 2020

End Date

March 27 2025

Last Update

April 2 2025

Active Locations (1)

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Leiden University Medical Center

Leiden, Netherlands

Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery | DecenTrialz