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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | Active Comparator | General anesthesia only Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Drop out criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pryambodho Pryambodho, MD, Anesthesiologist | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto mangunkusumo general hospital | Jakarta | Jakarta Special Capital Region | 10430 | Indonesia |
The data may be available upon request if needed.
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Two parallel groups - intervention and control group
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| General Anesthesia (control group) | Drug | Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg |
|
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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