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OpenTrials
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NCT Number: NCT06892600

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

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 to answer are:

Does combining spinal and general anesthesia provide better stability compared to general anesthesia alone during abdominal laparoscopic surgery? Does combining spinal and general anesthesia lead to less opioid consumption compared to general anesthesia alone for abdominal laparoscopic surgery?

Participants will:

Be randomized and allocated to either spinal and general anesthesia (combined) group vs general anesthesia (control) group In the combined group, participants will be given a spinal anesthesia followed by general anesthesia, compared to general anesthesia alone in the control group.

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Key information

Conditions

Laparoscopic Abdominal Surgery General Anesthesia Using Endotracheal Intubation Spinal Anesthesia

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto mangunkusumo general hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia

Drug

Combined spinal and general anesthesia Spinal anesthesia with Bupivacaine heavy 0.5% 10 mg General anesthesia with Lidocaine 1.5mg/kg, Fentanyl 2 mcg/kg, propofol 2 mg/kg, Rocuronium 0.6 mg/kg

General Anesthesia (control group)

Drug

Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg

Primary outcomes

  1. Opioid consumption

    Time frame: Throughout the surgery

    Fentanyl dosage in mcg used during the procedure

  2. Post-operative pain score

    Time frame: Within 24 hours after surgery

    Post operative pain score

  3. Hemodynamic stability

    Time frame: During the surgery

    Mean arterial pressure (MAP) after insufflation variation of < 20% compared to MAP after intubation

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2025
Registry last updated
Mar 25, 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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