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

University of Indonesia (UI)

Status: Completed

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

Treatments: Drug: Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia; Drug: General Anesthesia (control group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06892600

23060823

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Combined group

Experimental group

Description:

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

Treatment:

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

Control

Active Comparator group

Description:

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

Treatment:

Drug: General Anesthesia (control group)