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

NCT04597723 | Unknown Phase 3 DMC

• 1 other identifier: Selcuk University Konya
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oxygen; Postoperative Nausea and Vomiting

Keywords

postoperative nausea and vomiting; Oxygen

Outcome Measures

Primary Outcomes (2)

• severity of nausea

  severity of nausea was measured using a 10-cm visual analog scale, The patients were explained that 1 point indicated "no nausea" and 10 points indicated "severe nausea," and then they were asked to give 1-10 points for their severity of nausea.

  0-24 hours in the postoperative period

• severity of vomiting

  severity of vomiting was measured using a 10-cm visual analog scale, The patients were explained that 1 point indicated "no vomiting" and 10 points indicated "severe vomiting," and then they were asked to give 1-10 points for their severity of vomiting

  0-24 hours in the postoperative period

Study Arms (3)

80% oxygen

EXPERIMENTAL

80% oxygen given group

Drug: oxygen

60% oxygen

EXPERIMENTAL

60% oxygen given group

Drug: oxygen

routine hospital care

NO INTERVENTION

The patients in this group received routine hospital care.

Interventions

oxygen DRUG

Patients will be given different concentrations of oxygen.

60% oxygen; 80% oxygen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgery time is 2 hours or less
• The patient does not have peripheral vascular disease
• The patient does not have a psychiatric disorder
• The patient can communicate verbally
• The patient is not using anticoagulant drugs
• The patient's hemoglobin level in the preoperative period is in the range of 12-16 g / dL
• The patient's American Society of Anesthesiologist (ASA) value is between 1-2
• The patient is not smoking
• The patient is between 18 and 65 years old
• In the intraoperative period, the carbon dioxide gas pressure used to inflate the abdomen is between 10-12.
• The patient's willingness to participate in the research
• The patient does not have respiratory diseases (such as bronchitis)
• The patient does not have claustrophobia

You may not qualify if:

• \- The patient is using anticoagulant medication

Sponsors & Collaborators

• Selcuk University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Pınar tunç tuna

Konya, 42500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Hulya Bulut

  Gazi University

  STUDY CHAIR

• Sevil Guler Demir

  Gazi University

  STUDY CHAIR

• Faruk Cicekci

  Selcuk University

  STUDY CHAIR

• Hulagu Barıskaner

  Selcuk University

  STUDY CHAIR

• Mustafa Sahin

  Selcuk University

  STUDY CHAIR

• Inci Kara

  Selcuk University

  STUDY CHAIR

Central Study Contacts

Pınar t tuna

CONTACT

05069549225; pinartunctuna@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: May 3, 2022
• Primary Completion: January 3, 2023
• Study Completion: May 3, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

TU (1)