Laparoscopic Abdominal SurgeryNCT06892600
Combined General and Spinal Anesthesia Compared to General Anesthesia During Laparoscopic Surgery : a Randomised Controlled Trial
A study testing Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia in people with Laparoscopic Abdominal Surgery and Spinal Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Laparoscopic Abdominal Surgery, Spinal Anesthesia, General Anesthesia Using Endotracheal Intubation
- What is being tested?
- Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Aug 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto mangunkusumo general hospital
Jakarta, Jakarta Special Capital Region, 10430
About this study
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?
Read more
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
- Being tested
- Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia, General Anesthesia (control group)
- Keywords
- laparoscopy, combined spinal and general anesthesia, abdominal laparoscopic surgery, opioid consumption, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesiaDrug
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
General Anesthesia (control group)Drug
Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: General Anesthesia (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Fentanyl dosage in mcg used during the procedure
Measured: Throughout the surgery
Post-operative pain score
Post operative pain score
Measured: Within 24 hours after surgery
Hemodynamic stability
Mean arterial pressure (MAP) after insufflation variation of < 20% compared to MAP after intubation
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start3 Aug 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups - intervention and control group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
- Investigators
- Pryambodho Pryambodho, MD, Anesthesiologist, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892600
- Sponsor's protocol ID
- 23060823
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data may be available upon request if needed.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined General and Spinal Anesthesia Compared to General Anesthesia During Laparoscopic Surgery : a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06892600
- Acronym / sponsor ID
- 23060823
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups - intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Combined group | Experimental | Drug: Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesiaCombined 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 | Drug: General Anesthesia (control group)General anesthesia only Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesiaCombined 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 | Drug | Combined group |
| General Anesthesia (control group)Lidocaine 1.5mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg | Drug | Control |
Primary outcome
Opioid consumption
Time frame: Throughout the surgery
Fentanyl dosage in mcg used during the procedure
Post-operative pain score
Time frame: Within 24 hours after surgery
Post operative pain score
Hemodynamic stability
Time frame: During the surgery
Mean arterial pressure (MAP) after insufflation variation of < 20% compared to MAP after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No. The data may be available upon request if needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pryambodho Pryambodho, MD, Anesthesiologist principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Spinal anesthesia (heavy bupivacaine 0.5%) and General anesthesia in people with Laparoscopic Abdominal Surgery and Spinal Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: Throughout the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.