General Anesthesia Using Endotracheal Intubation, Laparoscopic Abdominal Surgery, Spinal Anesthesia
Conditions
Keywords
laparoscopy, combined spinal and general anesthesia, abdominal laparoscopic surgery, opioid consumption, spinal anesthesia
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.
Interventions
DRUGCombined 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
Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two parallel groups - intervention and control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed