Postoperative Nausea and VomitingPONV-RSCMNCT07688811
Risk Factors for Postoperative Nausea and Vomiting (PONV) in Adults at the Post-Anaesthesia Care Unit of Dr. Cipto Mangunkusumo National General Hospital
An observational study of Postoperative Nausea and Vomiting and Anesthesia Complication, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this observational study is to determine the incidence of postoperative nausea and vomiting (PONV) and identify its risk factors in adult patients recovering in the post-anaesthesia care unit (PACU) after elective surgery at RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting, Anesthesia Complication, Postoperative Complication
- What is being tested?
- Routine perioperative anaesthesia care
- How many people
- 280 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Jan 2026to 12 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (≥18 years) undergoing elective surgery under anaesthesia at the Central Surgical Installation (Instalasi Bedah Pusat) of RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia.
Who may be able to join
- Adult patients aged 18 years or older
- Scheduled to undergo elective surgery under any type of anaesthesia (general anaesthesia, spinal, epidural, or sedation)
- ASA (American Society of Anesthesiologists) physical status classification I-IV
- Fully conscious with a Glasgow Coma Scale (GCS) score of 15
Who cannot join
- Presence of nausea or vomiting before anaesthesia induction
- Use of Monitored Anaesthesia Care (MAC) technique
- Preoperative use of opioids or other emetogenic medications
- Patient or legal guardian refuses informed consent
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo (Dr. Cipto Mangunkusumo National General Hospital)
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Analysis of Risk Factors for Postoperative Nausea and Vomiting (PONV) in Adult Patients at the Post-Anaesthesia Care Unit (PACU) of RSUPN Dr. Cipto Mangunkusumo
The goal of this observational study is to determine the incidence of postoperative nausea and vomiting (PONV) and identify its risk factors in adult patients recovering in the post-anaesthesia care unit (PACU) after elective surgery at RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia. The main questions it aims to answer are:
- What is the incidence of PONV among adult patients during their PACU stay?
- Which patient-, anaesthesia-, and surgery-related factors are independently associated with the occurrence of PONV?
Read more
Participants who undergo elective surgery under any anaesthetic technique (general anaesthesia, spinal, epidural, or sedation) will be observed for nausea and vomiting from PACU admission until discharge. Researchers will also record the following variables for each participant:
- Patient factors: age, sex, smoking history, and history of motion sickness or prior PONV
- Anaesthesia factors: type of anaesthesia, intraoperative opioid use, and PONV prophylaxis use
- Surgical factors: type of surgery and surgical duration
- Being tested
- Routine perioperative anaesthesia care
- Keywords
- postoperative nausea and vomiting, post-anaesthesia care unit, apfel score, risk factors, prospective cohort
- Medical subject headings
- Postoperative Nausea and Vomiting, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine perioperative anaesthesia careOther
Participants undergo elective surgery with anaesthesia as part of their standard clinical care. No additional intervention is administered by the research team. The study observes participants during their routine post-anaesthesia care unit (PACU) stay and records exposure to anaesthesia-related factors (type of anaesthesia, opioid use, PONV prophylaxis) and surgical factors (surgery type, duration) as they occur in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Adult Elective Surgical Patients | Adult patients aged 18 years or older undergoing elective surgery under any anaesthetic technique (general anaesthesia, spinal, epidural, or sedation) at the Central Surgical Installation of RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia. Participants are observed from PACU admission until discharge for the occurrence of postoperative nausea and vomiting (PONV). Risk factor data collected include age, sex, smoking history, history of motion sickness or prior PONV, type of anaesthesia, intraoperative opioid use, PONV prophylaxis use, type of surgery, and surgical duration. Receives: Other: Routine perioperative anaesthesia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and/or vomiting (PONV) during PACU stay
PONV is defined as any episode of nausea (sensation of wanting to vomit without expulsive muscle movement) or vomiting (active expulsion of gastrointestinal contents) occurring after surgery with anaesthesia (general, spinal, epidural, or sedation). Assessed by direct clinical observation and patient interview during PACU monitoring.
Measured: Immediate postoperative period (Postoperative Day 0; during PACU stay)
Secondary outcomes (1)
Severity of PONV
Severity of PONV as assessed by Numeric Rating Scale (NRS): mild (1-3), moderate (4-6), severe (7-10)
Measured: Immediate postoperative period (Postoperative Day 0; during PACU stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start26 Jan 2026
- Primary completion26 Feb 2026
- Study completion12 Jul 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldy Heriwardito, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688811
- Sponsor's protocol ID
- IndonesiaUAnes637
- Acronym
- PONV-RSCM
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly in order to protect the privacy and confidentiality of study participants, in accordance with the ethics approval conditions set by KEPK FKUI-RSCM.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors for Postoperative Nausea and Vomiting (PONV) in Adult Patients at the Post-Anaesthesia Care Unit (PACU) of RSUPN Dr. Cipto Mangunkusumo
- ClinicalTrials.gov ID
- NCT07688811
- Acronym / sponsor ID
- PONV-RSCM / IndonesiaUAnes637
- Keywords
- postoperative nausea and vomiting, post-anaesthesia care unit, apfel score, risk factors, prospective cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 12 Jul 2026 (actual)
- First posted
- 7 Jul 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.
The goal of this observational study is to determine the incidence of postoperative nausea and vomiting (PONV) and identify its risk factors in adult patients recovering in the post-anaesthesia care unit (PACU) after elective surgery at RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia. The main questions it aims to answer are:
- What is the incidence of PONV among adult patients during their PACU stay?
- Which patient-, anaesthesia-, and surgery-related factors are independently associated with the occurrence of PONV?
Participants who undergo elective surgery under any anaesthetic technique (general anaesthesia, spinal, epidural, or sedation) will be observed for nausea and vomiting from PACU admission until discharge. Researchers will also record the following variables for each participant:
- Patient factors: age, sex, smoking history, and history of motion sickness or prior PONV
- Anaesthesia factors: type of anaesthesia, intraoperative opioid use, and PONV prophylaxis use
- Surgical factors: type of surgery and surgical duration
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Elective Surgical Patients | – | Other: Routine perioperative anaesthesia careAdult patients aged 18 years or older undergoing elective surgery under any anaesthetic technique (general anaesthesia, spinal, epidural, or sedation) at the Central Surgical Installation of RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia. Participants are observed from PACU admission until discharge for the occurrence of postoperative nausea and vomiting (PONV). Risk factor data collected include age, sex, smoking history, history of motion sickness or prior PONV, type of anaesthesia, intraoperative opioid use, PONV prophylaxis use, type of surgery, and surgical duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) undergoing elective surgery under anaesthesia at the Central Surgical Installation (Instalasi Bedah Pusat) of RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older
- Scheduled to undergo elective surgery under any type of anaesthesia (general anaesthesia, spinal, epidural, or sedation)
- ASA (American Society of Anesthesiologists) physical status classification I-IV
- Fully conscious with a Glasgow Coma Scale (GCS) score of 15
Key exclusion criteria (4 listed)
- Presence of nausea or vomiting before anaesthesia induction
- Use of Monitored Anaesthesia Care (MAC) technique
- Preoperative use of opioids or other emetogenic medications
- Patient or legal guardian refuses informed consent
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 |
|---|---|---|
| Routine perioperative anaesthesia careParticipants undergo elective surgery with anaesthesia as part of their standard clinical care. No additional intervention is administered by the research team. The study observes participants during their routine post-anaesthesia care unit (PACU) stay and records exposure to anaesthesia-related factors (type of anaesthesia, opioid use, PONV prophylaxis) and surgical factors (surgery type, duration) as they occur in clinical practice. | Other | Adult Elective Surgical Patients |
Primary outcome
Incidence of postoperative nausea and/or vomiting (PONV) during PACU stay
Time frame: Immediate postoperative period (Postoperative Day 0; during PACU stay)
PONV is defined as any episode of nausea (sensation of wanting to vomit without expulsive muscle movement) or vomiting (active expulsion of gastrointestinal contents) occurring after surgery with anaesthesia (general, spinal, epidural, or sedation). Assessed by direct clinical observation and patient interview during PACU monitoring.
1 secondary outcome
Severity of PONV
Time frame: Immediate postoperative period (Postoperative Day 0; during PACU stay)
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 14 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly in order to protect the privacy and confidentiality of study participants, in accordance with the ethics approval conditions set by KEPK FKUI-RSCM.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting and Anesthesia Complication, 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 4 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 14 Jul 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.
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/or vomiting (PONV) during PACU stay (time frame: Immediate postoperative period (Postoperative Day 0; during PACU stay)). 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 14 Jul 2026.