NCT07688811

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

March 22, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

postoperative nausea and vomitingpost-anaesthesia care unitapfel scorerisk factorsprospective cohort

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediate postoperative period (Postoperative Day 0; during PACU stay)

Secondary Outcomes (1)

  • Severity of PONV

    Immediate postoperative period (Postoperative Day 0; during PACU stay)

Study Arms (1)

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.

Other: Routine perioperative anaesthesia care

Interventions

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.

Adult Elective Surgical Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo (Dr. Cipto Mangunkusumo National General Hospital)

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthesiologist, Department of Anaesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo Hospital

Study Record Dates

First Submitted

March 22, 2026

First Posted

July 7, 2026

Study Start

January 26, 2026

Primary Completion

February 26, 2026

Study Completion

July 12, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations