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

NCT ID: NCT06892600

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2023-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Control

General anesthesia only Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg

Group Type: ACTIVE_COMPARATOR

General Anesthesia (control group)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

General Anesthesia (control group)

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Pryambodho Pryambodho

MD, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pryambodho Pryambodho, MD, Anesthesiologist

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Cipto mangunkusumo general hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

23060823

Identifier Type: -

Identifier Source: org_study_id