NCT05970055

Brief Summary

Postoperative nausea and vomiting (PONV) is a surgical complication defined as any nausea, and vomiting with in the first 24-48 hours after surgery in inpatients. Nausea is an unpleasant feeling or desire to vomit without expulsive muscular movement, while vomiting is a forceful expulsion or reflux of the gastric contents through the mouth. Postoperative nausea and vomiting is one of the most common complication associated anesthesia and surgery. It is considered the most common cause of morbidity, and it has significant effects on patient satisfaction. In spite of recent development of anesthesia and surgical techniques, the incidence of PONV remains high. This common anesthetic and surgical side effect has been reported to increase patient dissatisfaction and can be just as distressing to patients as postoperative pain is.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
677

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 23, 2023

Last Update Submit

July 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • post-operative nausea and vomiting

    Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery.

    24 hours

Study Arms (1)

PONV and Non PONV

PONV- patients who developed nausea and vomiting postoperatively Non PONV- patients who did not develop nausea and vomiting postoperatively

Procedure: elective surgery

Interventions

All elective surgical procedures performed under the study period will be included.

PONV and Non PONV

Eligibility Criteria

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

All adult, elective patients who underwent elective surgery under anesthesia at the Dessie comprehensive specialized hospital during the study period

You may qualify if:

  • All adult patients, who underwent elective surgery under anesthesia in the study period.

You may not qualify if:

  • Patients who didn't gain their consciousness postoperatively, patients who underwent emergency surgery, patients who were re-operated on during the study period, surgical patients medical illness that predispose them to nausea and vomiting, and patients discharged before 24 hours postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wollo Univeersity

Dessie, 1145, Ethiopia

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Sara Timerga

    Wollo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

February 1, 2022

Primary Completion

April 30, 2022

Study Completion

July 30, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations