The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting

April 28, 2024 updated by: Zeynep sym, Ankara City Hospital Bilkent

The Role of High Intraoperative Fraction of Inspired Oxygen in Preventing Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants will be monitored with electrocardiogram, pulse oximeter , non-invasive blood pressure. The fasting period of the patients was 8 hours. The participants were randomly divided into two groups by the auxiliary health personnel using the closed envelope draw method. After the participants were taken to the operating room, their files were checked, consent for the study was obtained, and the Apfel score was noted. Participants were started on intravenous crystalloid fluid infusion at 8ml/kg/hour. After induction of general anesthesia with 0.03mg/kg midazolam, 2-2.5 mg/kg propofol, 1 µg/kg remifentanil, 0.6 mg/kg rocuronium, the participants were intubated and connected to the anesthesia machine, with sevoflurane and maintenance administered at minimum alveolar concentration 1.3. was achieved with remifentanil infusion. After the participants were connected to the anesthesia device, the tidal volume was adjusted to 7 ml/kg, respiratory rate 12-14/min, positive end-expiratory pressure 5 cmH2O, flow 2 liter/min, Fraction of inspired oxygen 30% in Group I and 80% in Group 2. Gastric fluid and air were aspirated from the participants using an orogastric tube. The participants' vitals were monitored intraoperatively at 5-minute intervals and recorded every 15 minutes. Intra-abdominal pressure was kept between 10-12 mmHg. Approximately 15 minutes before the end of the surgical procedure, remifentanil infusion was stopped, and 1 g paracetamol and 50 mg dexketoprofen i.v. were administered as postoperative analgesics was given. No narcotic analgesics were given. At the end of the operation, exsufflation was performed before the trocars were removed and the intra-abdominal pressure was allowed to return to normal. The surgical team was given bupivacaine to administer 15 mg per trocar site. While the last few skin stitches were being placed, sevoflurane was discontinued in all participants and they were switched to 100% oxygen. Muscle relaxant antagonism was achieved with sugammadex (2 mg/kg) in both groups. The patients were extubated and monitored for 1 hour postoperatively in the recovery unit. All patients were given 2 liter/min O2 in the recovery unit. In case of nausea and vomiting, the Nausea Vomiting Score is noted and 4 mg of ondansetron i.v. is given to patients with moderate to severe nausea and vomiting. Participants requiring additional analgesics were given 100 mg tramadol. Postoperative 24-hour nausea and vomiting was monitored in the patient's hospitalization ward. The participants with nausea and vomiting during the 24-hour follow-up were learned from the follow-up doctor and noted on the follow-up forms. During the ward follow-up, patients with nausea were given 4mg of ondansetron.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bilkent
      • Ankara, Bilkent, Turkey
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
grup I
Intraoperative Fraction of Inspired Oxygen %30 applied
Procedure: intraoperative Fraction of Inspired Oxygen
Group I intraoperative Fraction of Inspired Oxygen 30%, Group II intraoperative Fraction of Inspired Oxygen 80% applied group.
grup II
Intraoperative Fraction of Inspired Oxygen %80 applied
Procedure: intraoperative Fraction of Inspired Oxygen
Group I intraoperative Fraction of Inspired Oxygen 30%, Group II intraoperative Fraction of Inspired Oxygen 80% applied group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: at the postoperative 15.minutes
the investigators aimed to compare postoperative nause and vomiting
at the postoperative 15.minutes
Postoperative nausea and vomiting 24.hours
Time Frame: at the postoperative 24.hours
the investigators aimed to compare postoperative nause and vomiting
at the postoperative 24.hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative antiemetic 15. minutes
Time Frame: at the postoperative 15.minutes
the investigators aimed to compare postoperative making antiemetic medication
at the postoperative 15.minutes
Postoperative antiemetic 24.hours
Time Frame: at the postoperative 24.hours
the investigators aimed to compare postoperative making antiemetic medication
at the postoperative 24.hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2-22-2167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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