NCT04597723

The Effect of Oxygen Given to Patients in the Postoperative Period on Nausea and Vomiting

Status unknown Phase 3 Last updated 22 October 2020

What this trial tests

Phase 3 trial testing oxygen in Oxygen in 111 participants. Status unknown.

Timeline

3 May 2022

Primary endpoint
3 January 2023

3 May 2023

Quick facts

Lead sponsor	Selcuk University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	111
Start date	3 May 2022
Primary completion	3 January 2023
Estimated completion	3 May 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• oxygen — full drug profile →

Conditions studied

• Oxygen — all drugs for Oxygen →
• Postoperative Nausea and Vomiting — all drugs for Postoperative Nausea and Vomiting →

Sponsor

Selcuk University

Who can join

Adults 18 to 65, female only, with Oxygen or Postoperative Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Carbon dioxide which is insufflated to inflate the abdominal area is absorbed from the peritoneal area and it increases endogenous catecholamines, which may consequently increase nausea and vomiting. In the literature, it is indicated that oxygen application which is one of the applications aiming to prevent nausea and vomiting is a cheap method with fewer side effects in the prevention of postoperative nausea and vomiting.

In the literature, studies on the prevention of nausea and vomiting by oxygen application in different surgical interventions have not arrived at a consensus regarding surgery type and oxygen amounts. There are studies evaluating 80% and 30% oxygen amounts in removing postoperative nausea and vomiting. Taking these conditions into consideration; the study has been planned for the purpose of examining the impact of giving 80% and 60% oxygen to patients to whom laparoscopic cholecystectomy is applied on postoperative nausea and vomiting in the postoperative period.

The study has been planned as a randomized controlled study for the purpose of determining the impact of giving oxygen (80% to the group A, 60% to the group B and control group C) to patients who apply to the general surgery service to undergo a laparoscopic cholecystectomy on postoperative nausea and vomiting in the postoperative period. The patients in the study will have the same standard anesthesia protocol and hospital routine. The study will be terminated once a total of 111 patients have been reached. In the study randomization, the patients will be assigned to the sample group according to weeks as they may influence each other. Data will be collected using Patient Introductory Information Form, which evaluates patients' socio-demographic characteristics, as well as Perioperative Period Patient Follow-Up Form and Postoperative Period Nausea-Vomiting Frequency and Severity Evaluation Form. Statistical analysis of the data to be acquired as a result of the study will be performed in the computer environment. The results to be obtained will be evaluated at p\<0,05 significance level.

It is expected that the study results will provide an alternative method, which will be used in preventing the possible side effects of postoperative nausea and vomiting in patients who undergo a laparoscopic cholecystectomy. Thus, the study results may make scientific and socio-economic contributions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.