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

Not Applicable

Completed

• Conditions: Laparoscopic Abdominal Surgery; Spinal Anesthesia; General Anesthesia Using Endotracheal Intubation
• Interventions: Drug: Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia; Drug: General Anesthesia (control group)

• Registration Number: NCT06892600
• Lead Sponsor: Indonesia University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-03
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined group	Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia	Combined spinal anesthesia and general anesthesia Spinal anesthesia is given at L2-3/L3-4 level with Quincke 27G spinal needle, with 10 mg of Bupivacaine heavy 0.5% General anesthesia is induced with lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg
Control	General Anesthesia (control group)	General anesthesia only Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg

Primary Outcome Measures

Name	Time	Method
Opioid consumption	Throughout the surgery	Fentanyl dosage in mcg used during the procedure
Post-operative pain score	Within 24 hours after surgery	Post operative pain score
Hemodynamic stability	During the surgery	Mean arterial pressure (MAP) after insufflation variation of \< 20% compared to MAP after intubation

Trial Locations

Locations (1)

Cipto mangunkusumo general hospital; 🇮🇩 Jakarta, Indonesia