Postoperative Nausea and VomitingPhase 4NCT07851870
Spinal Morphine and Atropine Added to General Anaesthesia for Nausea and Pain After Abdominal Laparoscopy
A Phase 4 study testing Intrathecal bupivacaine, morphine and atropine, General anaesthesia and Multimodal analgesia and antiemetic prophylaxis in people with Postoperative Nausea and Vomiting and Postoperative Pain, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Laparoscopic abdominal surgery carries one of the highest risks of postoperative nausea and vomiting (PONV), and postoperative opioids given for pain are themselves emetogenic. Intrathecal morphine provides prolonged analgesia but increases nausea; intrathecal atropine 100 µg has been reported to reduce… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Postoperative Pain, Anesthesia
- What is being tested?
- Intrathecal bupivacaine, morphine and atropine, General anaesthesia and Multimodal analgesia and antiemetic prophylaxis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Feb 2026to 26 Mar 2026
- Phase
- Phase 4
- 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
- Aged 18 to 64 years
- ASA physical status I or II
- Body mass index 30 kg/m² or less
- Scheduled for elective digestive, gynaecological or urological laparoscopy
- Written informed consent given
Who cannot join
- Uncontrolled stage 2 hypertension
- Heart failure, arrhythmia, valvular heart disease or atrioventricular block
- Cerebrovascular event within the previous 3 months
- Raised intracranial pressure
- Severe renal or hepatic disease
- Coagulopathy
- Infection at the site of lumbar puncture
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Central General Hospital (RSCM)
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Title Combined Spinal-General Anaesthesia With Low-Dose Intrathecal Morphine and Atropine for Abdominal Laparoscopy: A Randomised Controlled Trial of Postoperative Nausea, Vomiting and Pain
Laparoscopic abdominal surgery carries one of the highest risks of postoperative nausea and vomiting (PONV), and postoperative opioids given for pain are themselves emetogenic. Intrathecal morphine provides prolonged analgesia but increases nausea; intrathecal atropine 100 µg has been reported to reduce morphine-related nausea under spinal anaesthesia alone, but has not been tested within a combined spinal-general technique.
This randomised, open-label, parallel-group trial compared combined spinal-general anaesthesia (CSGA), hyperbaric bupivacaine 10 mg, morphine 100 µg and atropine 100 µg given intrathecally before induction, followed by general anaesthesia, with general anaesthesia (GA) alone in adults undergoing elective abdominal laparoscopy. Both groups received identical general anaesthesia, multimodal analgesia (paracetamol and ketorolac at skin closure), end-of-case ondansetron and neostigmine-atropine reversal.
The primary outcome was the occurrence of PONV within 24 hours after surgery. Secondary outcomes were postoperative pain, rescue antiemetic and rescue opioid requirements, intraoperative fentanyl consumption and perioperative haemodynamics.
Read the detailed description
summarise Methods: setting, randomisation by computer-generated sequence, spinal technique at L4-5 with 27-G Quincke needle, target T6 block, induction and maintenance regimen, assessment schedule at 1, 2, 6, 12 and 24 h, sample size assumptions of 75% vs 40% PONV at α 0.05 and 80% power, per-protocol analysis.
- Conditions
- Postoperative Nausea and Vomiting, Postoperative Pain, Anesthesia, Anesthesia Spinal, Laparoscopy
- Being tested
- Intrathecal bupivacaine, morphine and atropine, General anaesthesia, Multimodal analgesia and antiemetic prophylaxis
- Keywords
- Atropine, Intrathecal, Morphine, Spinal anaesthesia, PONV, Laparoscopy, Opioid sparing
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal bupivacaine, morphine and atropineDrug
Hyperbaric bupivacaine 10 mg + preservative-free morphine 100 µg + atropine sulphate 100 µg in 4 mL, single intrathecal injection before induction
General anaesthesiaProcedure or surgery
Lidocaine, fentanyl, propofol, rocuronium induction; sevoflurane maintenance; neostigmine-atropine reversal
Multimodal analgesia and antiemetic prophylaxisDrug
Paracetamol 1 g and ketorolac 30 mg IV at skin closure; ondansetron 4 mg IV at end of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Combined spinal-general anaesthesia (CSGA) | Experimental | Before induction, spinal anaesthesia at L4-5 in the sitting position with a 27-G Quincke needle: 0.5% hyperbaric bupivacaine 10 mg, preservative-free morphine 100 µg and atropine sulphate 100 µg, made up to 4 mL with 0.9% saline, targeting a T6 sensory level. General anaesthesia was then induced and maintained as in the comparator arm. Receives: Drug: Intrathecal bupivacaine, morphine and atropine; Procedure: General anaesthesia; Drug: Multimodal analgesia and antiemetic prophylaxis |
| GA alone | Active comparator | General anaesthesia without any neuraxial block: induction with lidocaine 1.5 mg/kg, fentanyl 2 µg/kg, propofol 2 mg/kg and rocuronium 0.6 mg/kg; maintenance with sevoflurane in oxygen-air at target MAC 0.8, with fentanyl 25-50 µg boluses for haemodynamic response. Receives: Procedure: General anaesthesia; Drug: Multimodal analgesia and antiemetic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting (PONV)
Proportion of participants with a score of 1 or more on a 5-point PONV analogue visual scale (0 = none; 1 = nausea <10 min or one vomit, no treatment; 2 = nausea >10 min or two vomits, no treatment; 3 = nausea >10 min or more than two vomits requiring treatment; 4 = refractory to treatment), assessed at 1 h in recovery and at 2, 6, 12 and 24 h on the ward. Higher scores indicate worse outcome.
Measured: Within 24 hours after surgery
Secondary outcomes (8)
Postoperative pain intensity
11-point Numeric Rating Scale, 0 = no pain to 10 = worst imaginable pain; higher = worse.
Measured: 2, 6, 12 and 24 hours after surgery
Number of participants requiring rescue morphine
morphine 2 mg IV given for NRS greater than 6.
Measured: Within 24 hours
Number of participants requiring rescue ondansetron
ondansetron 4 mg IV given for PONV score of 3 or more.
Measured: Within 24 hours
Total post-induction fentanyl dose
Total post-induction fentanyl dose
Measured: Intraoperative period, from induction to end of anaesthesia
Mean arterial pressure
mmHg, non-invasive.
Measured: Pre-induction, after spinal injection, at and after insufflation, after desufflation, after extubation (intraoperative period)
Heart rate
beats per minute
Measured: Pre-induction, after spinal injection, at and after insufflation, after desufflation, after extubation (intraoperative period)
Number of participants requiring vasopressor support
Measured: Intraoperative period
Number of participants with heart rate below 50 beats/min
as a safety measure for the intrathecal atropine.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start2 Feb 2026
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel-assignment design. Eligible adults undergoing elective abdominal laparoscopy were allocated in a 1:1 ratio to combined spinal-general anaesthesia or general anaesthesia alone, using a random sequence generated by a research assistant with www.randomizer.org. No allocation concealment or masking was used; the allocation sequence was known to the investigators throughout. Consent was obtained by a researcher not involved in the participant's clinical care. Each participant received one allocated technique only, with no crossover.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
- Investigators
- Pryambodho Pryambodho, MD, Principal investigator, Department of Anesthesiology and Intensive Care, FKUI-RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851870
- Sponsor's protocol ID
- 2106795356
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The informed consent obtained from participants and the ethics approval for this study provided for research data to be kept confidential, with access limited to regulatory authorities for verification purposes, and did not include provision for sharing individual-level data with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title Combined Spinal-General Anaesthesia With Low-Dose Intrathecal Morphine and Atropine for Abdominal Laparoscopy: A Randomised Controlled Trial of Postoperative Nausea, Vomiting and Pain
- ClinicalTrials.gov ID
- NCT07851870
- Acronym / sponsor ID
- 2106795356
- Conditions
- Postoperative Nausea and Vomiting, Postoperative Pain, Anesthesia, Anesthesia Spinal, Laparoscopy
- Keywords
- Atropine, Intrathecal, Morphine, Spinal anaesthesia, PONV, Laparoscopy, Opioid sparing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 1 Oct 2026 (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.
Laparoscopic abdominal surgery carries one of the highest risks of postoperative nausea and vomiting (PONV), and postoperative opioids given for pain are themselves emetogenic. Intrathecal morphine provides prolonged analgesia but increases nausea; intrathecal atropine 100 µg has been reported to reduce morphine-related nausea under spinal anaesthesia alone, but has not been tested within a combined spinal-general technique.
This randomised, open-label, parallel-group trial compared combined spinal-general anaesthesia (CSGA), hyperbaric bupivacaine 10 mg, morphine 100 µg and atropine 100 µg given intrathecally before induction, followed by general anaesthesia, with general anaesthesia (GA) alone in adults undergoing elective abdominal laparoscopy. Both groups received identical general anaesthesia, multimodal analgesia (paracetamol and ketorolac at skin closure), end-of-case ondansetron and neostigmine-atropine reversal.
The primary outcome was the occurrence of PONV within 24 hours after surgery. Secondary outcomes were postoperative pain, rescue antiemetic and rescue opioid requirements, intraoperative fentanyl consumption and perioperative haemodynamics.
Detailed description
summarise Methods: setting, randomisation by computer-generated sequence, spinal technique at L4-5 with 27-G Quincke needle, target T6 block, induction and maintenance regimen, assessment schedule at 1, 2, 6, 12 and 24 h, sample size assumptions of 75% vs 40% PONV at α 0.05 and 80% power, per-protocol analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group parallel-assignment design. Eligible adults undergoing elective abdominal laparoscopy were allocated in a 1:1 ratio to combined spinal-general anaesthesia or general anaesthesia alone, using a random sequence generated by a research assistant with www.randomizer.org. No allocation concealment or masking was used; the allocation sequence was known to the investigators throughout. Consent was obtained by a researcher not involved in the participant's clinical care. Each participant received one allocated technique only, with no crossover.
| Arm | Type | Receives |
|---|---|---|
| Combined spinal-general anaesthesia (CSGA) | Experimental | Drug: Intrathecal bupivacaine, morphine and atropine, Procedure: General anaesthesia, Drug: Multimodal analgesia and antiemetic prophylaxisBefore induction, spinal anaesthesia at L4-5 in the sitting position with a 27-G Quincke needle: 0.5% hyperbaric bupivacaine 10 mg, preservative-free morphine 100 µg and atropine sulphate 100 µg, made up to 4 mL with 0.9% saline, targeting a T6 sensory level. General anaesthesia was then induced and maintained as in the comparator arm. |
| GA alone | Active comparator | Procedure: General anaesthesia, Drug: Multimodal analgesia and antiemetic prophylaxisGeneral anaesthesia without any neuraxial block: induction with lidocaine 1.5 mg/kg, fentanyl 2 µg/kg, propofol 2 mg/kg and rocuronium 0.6 mg/kg; maintenance with sevoflurane in oxygen-air at target MAC 0.8, with fentanyl 25-50 µg boluses for haemodynamic response. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 64 years
- ASA physical status I or II
- Body mass index 30 kg/m² or less
- Scheduled for elective digestive, gynaecological or urological laparoscopy
- Written informed consent given
Key exclusion criteria (7 listed)
- Uncontrolled stage 2 hypertension
- Heart failure, arrhythmia, valvular heart disease or atrioventricular block
- Cerebrovascular event within the previous 3 months
- Raised intracranial pressure
- Severe renal or hepatic disease
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 |
|---|---|---|
| Intrathecal bupivacaine, morphine and atropineHyperbaric bupivacaine 10 mg + preservative-free morphine 100 µg + atropine sulphate 100 µg in 4 mL, single intrathecal injection before induction | Drug | Combined spinal-general anaesthesia (CSGA) |
| General anaesthesiaLidocaine, fentanyl, propofol, rocuronium induction; sevoflurane maintenance; neostigmine-atropine reversal | Procedure or surgery | Combined spinal-general anaesthesia (CSGA), GA alone |
| Multimodal analgesia and antiemetic prophylaxisParacetamol 1 g and ketorolac 30 mg IV at skin closure; ondansetron 4 mg IV at end of anaesthesia | Drug | Combined spinal-general anaesthesia (CSGA), GA alone |
Primary outcome
Incidence of postoperative nausea and vomiting (PONV)
Time frame: Within 24 hours after surgery
Proportion of participants with a score of 1 or more on a 5-point PONV analogue visual scale (0 = none; 1 = nausea <10 min or one vomit, no treatment; 2 = nausea >10 min or two vomits, no treatment; 3 = nausea >10 min or more than two vomits requiring treatment; 4 = refractory to treatment), assessed at 1 h in recovery and at 2, 6, 12 and 24 h on the ward. Higher scores indicate worse outcome.
8 secondary outcomes
Postoperative pain intensity
Time frame: 2, 6, 12 and 24 hours after surgery
Number of participants requiring rescue morphine
Time frame: Within 24 hours
Number of participants requiring rescue ondansetron
Time frame: Within 24 hours
Total post-induction fentanyl dose
Time frame: Intraoperative period, from induction to end of anaesthesia
Mean arterial pressure
Time frame: Pre-induction, after spinal injection, at and after insufflation, after desufflation, after extubation (intraoperative period)
Heart rate
Time frame: Pre-induction, after spinal injection, at and after insufflation, after desufflation, after extubation (intraoperative period)
Number of participants requiring vasopressor support
Time frame: Intraoperative period
Number of participants with heart rate below 50 beats/min
Time frame: intraoperative
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The informed consent obtained from participants and the ethics approval for this study provided for research data to be kept confidential, with access limited to regulatory authorities for verification purposes, and did not include provision for sharing individual-level data with third parties.
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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 principal investigator
Department of Anesthesiology and Intensive Care, FKUI-RSCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal bupivacaine, morphine and atropine, General anaesthesia and Multimodal analgesia and antiemetic prophylaxis in people with Postoperative Nausea and Vomiting and Postoperative Pain, 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 5 inclusion and 7 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 1 Oct 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of postoperative nausea and vomiting (PONV) (time frame: Within 24 hours after surgery). 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 1 Oct 2026.