NCT06226922

Brief Summary

The purpose of this study is to identify the risk factors for postoperative nausea and vomiting (PONV) in surgical patients undergoing patient-controlled intravenous analgesia (PCIA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 18, 2024

Last Update Submit

January 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • PCIA-PONV

    Patient-controlled intravenous analgesia (PCIA) was provided after surgery and a dedicated anesthesiologist conducted follow-up. Routine bedside visits were conducted twice a day during the PCIA procedure to evaluate the patient's postoperative nausea and vomiting. The degree of nausea was evaluated using the visual analogue scale (VAS), with 0 indicating no nausea or vomiting and 10 indicating the most severe form of unbearable nausea or vomiting. When the PONV score was greater than 4 or vomiting occurs, it was defined as PCIA-PONV.

    During the PCIA procedure after surgery

Secondary Outcomes (1)

  • PCIA-POV

    During the PCIA procedure after surgery

Study Arms (2)

PCIA-PONV Group

Patient-controlled intravenous analgesia (PCIA) will be used after surgery. Patients will receive dedicated follow-up. Routine bedside visits will be conducted twice daily after surgery to assess postoperative nausea and vomiting (PONV). The severity of nausea will be evaluated using the Visual Analogue Scale (VAS), where 0 indicates no nausea and vomiting, and 10 represents the most unbearable nausea and vomiting. When the PONV score is \>0 or vomiting occurs, it is defined as the PCIA-PONV group.

Other: No intervention

None PCIA-PONV Group

Patient-controlled intravenous analgesia (PCIA) will be used after surgery. Patients will receive dedicated follow-up. Routine bedside visits will be conducted twice daily after surgery to assess postoperative nausea and vomiting (PONV). The severity of nausea will be evaluated using the Visual Analogue Scale (VAS), where 0 indicates no nausea and vomiting, and 10 represents the most unbearable nausea and vomiting. When the PONV score is 0, it is defined as the None PCIA-PONV Group.

Other: No intervention

Interventions

No intervention

None PCIA-PONV GroupPCIA-PONV Group

Eligibility Criteria

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

Patients who underwent surgery at Peking Union Medical College Hospital from July 1, 2023 to October 31, 2023 and received patient-controlled intravenous analgesia after surgery

You may qualify if:

  • Age ≥ 18 years
  • Hospitalized patients
  • Undergoing general anesthesia during surgery

You may not qualify if:

  • Day surgery patients
  • Accepting PCIA for less than 24 hours
  • Medical record information is missing or unavailable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Shen Le, PhD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 26, 2024

Study Start

July 1, 2023

Primary Completion

October 31, 2023

Study Completion

November 30, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations