NCT06390280

Brief Summary

Postoperative nausea and vomiting is one of the most common complications after laparoscopic surgeries. The investigators aimed to evaluate the effects of intraoperative high fraction of inspired oxygen in preventing postoperative nausea and vomiting according to Apfel score in laparoscopic cholecystectomy patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

July 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

November 14, 2023

Last Update Submit

April 28, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postoperative nausea and vomiting

    the investigators aimed to compare postoperative nause and vomiting

    at the postoperative 15.minutes

  • Postoperative nausea and vomiting 24.hours

    the investigators aimed to compare postoperative nause and vomiting

    at the postoperative 24.hours

Secondary Outcomes (2)

  • Postoperative antiemetic 15. minutes

    at the postoperative 15.minutes

  • Postoperative antiemetic 24.hours

    at the postoperative 24.hours

Study Arms (2)

grup I

Intraoperative Fraction of Inspired Oxygen %30 applied

Procedure: intraoperative Fraction of Inspired Oxygen

grup II

Intraoperative Fraction of Inspired Oxygen %80 applied

Procedure: intraoperative Fraction of Inspired Oxygen

Interventions

Group I intraoperative Fraction of Inspired Oxygen 30%, Group II intraoperative Fraction of Inspired Oxygen 80% applied group.

grup Igrup II

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 98 patients, under the age of 60, in the ASA I-II risk group, who underwent laparoscopic cholecystectomy surgery were included.

You may qualify if:

  • Patients undergoing elective laparoscopy cholecystectomy surgery
  • Patients younger than 60 years old
  • Both genders
  • American Society of Anesthesiologists (ASA) I-II risk group

You may not qualify if:

  • pregnancy, patients who do not want to participate in the study, surgery time \> 2 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Bilkent, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2023

First Posted

April 30, 2024

Study Start

July 10, 2022

Primary Completion

January 30, 2023

Study Completion

February 28, 2023

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations