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

NCT06892600 | Completed

• 1 other identifier: 23060823
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Abdominal Surgery; Spinal Anesthesia; General Anesthesia Using Endotracheal Intubation

Keywords

laparoscopy; combined spinal and general anesthesia; abdominal laparoscopic surgery; opioid consumption; spinal anesthesia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Combined group

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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)

Interventions

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

Combined group

General Anesthesia (control group) DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto mangunkusumo general hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Interventions

Anesthesia, General; Control Groups

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pryambodho Pryambodho, MD, Anesthesiologist

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist

Model Details: Two parallel groups - intervention and control group

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: August 3, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)