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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Cipto mangunkusumo general hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined group; 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	Drug: Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia; 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
Active Comparator: Control; General anesthesia only Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg	Drug: General Anesthesia (control group); Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Pryambodho Pryambodho, MD, Anesthesiologist, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: laparoscopy; spinal anesthesia; opioid consumption; abdominal laparoscopic surgery; combined spinal and general anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Anesthetics
• Other Study ID Numbers: 23060823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data may be available upon request if needed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No