Status:

COMPLETED

Combined General and Spinal Anesthesia Compared to General Anesthesia During Laparoscopic Surgery : a Randomised Controlled Trial

Lead Sponsor:

Indonesia University

Conditions:

Laparoscopic Abdominal Surgery

Spinal Anesthesia

Eligibility:

All Genders

18-64 years

Phase:

NA

Brief Summary

The goal of this clinical trial is to learn if combining spinal and general anesthesia is better than general anesthesia alone for abdominal laparoscopic surgery in adults. The main questions it aims ...

Eligibility Criteria

Inclusion

  • American Society of Anesthesiology (ASA) 1-2
  • BMI ≤ 30 kg/m2
  • Adults (18-64 years old) who will undergo elective abdominal laparoscopic surgery (digestive surgery, gynecologic surgery or urologic surgery)
  • Willing to participate in this study

Exclusion

  • Cardiovascular disease (uncontrolled stage 2 hypertension, AV block, valvular heart disease, heart failure or arrythmia)
  • Cerebrovascular disease (within \< 3 months)
  • Infection at the proposed site of spinal injection
  • Coagulopathy
  • Elevated intracranial pressure
  • Severe kidney or liver dysfunction
  • Drop out criteria:
  • Anesthesia duration \> 6 hours
  • Intraoperative emergency
  • Conversion to open laparotomy
  • Spinal complications (shock, anaphylaxis, seizure or high spinal)
  • Failed spinal (2 attempts)

Key Trial Info

Start Date :

August 3 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 31 2023

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06892600

Start Date

August 3 2023

End Date

October 31 2023

Last Update

March 25 2025

Active Locations (1)

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Cipto mangunkusumo general hospital

Jakarta, Jakarta Special Capital Region, Indonesia, 10430