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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05970055
Other study ID # WolloU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date July 30, 2022

Study information

Verified date July 2023
Source Wollo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Postoperative nausea and vomiting is caused by multiple factors; patient related, anesthesia and surgery related risk factors have been identified. Patient related factors include female gender post-puberty, nonsmoking status, history of PONV or motion sickness, and childhood after infancy and younger adulthood. Use of volatile anesthetics, nitrous oxide, large-dose neostigmine, or intraoperative or postoperative opioids are factors related to anesthesia, while the type of procedures like gynecologic, ophthalmological, ontological, thyroid surgery laparoscopic, abdominal surgery and duration of the procedure are some of surgery related risk factors. The incidence of PONV for over multiple individual studies conducted around the world, has been estimated to be 25% to 30% and up to 80% in high risk groups. The incidence of PONV is estimated to range from 20%-36%. Post-operative nausea and vomiting imposes multiple impacts on patients. The main one being a decrease satisfaction, but more importantly it leads to dehydration, electrolyte imbalance, aspiration of gastric secretions, esophageal rupture, bleeding, increased morbidity, and delayed discharge from hospital. The study aimed to assess the incidence and associated factors of post-operative nausea and vomiting, which is believed to be a main contributing factor to dissatisfaction and delayed recovery seen in our country. The study was done from February to April 2022 in patients undergoing elective surgery at Dessie comprehensive specialized hospital, Ethiopia.


Recruitment information / eligibility

Status Completed
Enrollment 677
Est. completion date July 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adult patients, who underwent elective surgery under anesthesia in the study period. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Ethiopia Wollo Univeersity Dessie

Sponsors (1)

Lead Sponsor Collaborator
Sara Timerga

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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