Effect of Fresh Gas Flow Differences on Postoperative Nausea and Vomiting

January 13, 2026 updated by: Ufuk Karbaş, Adiyaman University Research Hospital

Effects of Different Fresh Gas Flow Applications on Postoperative Nausea and Vomiting in Septorhinoplasty Surgeries

The aim of this study is to investigate the effect of fresh gas flow applied during general anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing septorhinoplasty surgery. Patients who agree to participate in the study will be divided into three groups according to the fresh gas flow applied: low flow (0.5 lt/min) (Group L), medium flow (2 lt/min) (Group M) and high flow (4 lt/min) (Group H), and the postoperative nausea and vomiting data of the groups will be compared.

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

Preoperative demographic characteristics and Apfel score (smoking history, gender, postoperative opioid use, POB history) of the patients will be recorded. General anesthesia will be applied to all patients with standard ASA monitoring. In general anesthesia induction, 2 mg/kg propofol, 1 mcg/kg remifentanil, 0.6 mg/kg rocuronium will be used for all patients. Sevoflurane (minimum alveolar concentration of 1) will be used as a volatile agent and remifentanil (0.1 mcg-1 mcg/kg/h) will be used as an analgesic agent for anesthesia maintenance. After endotracheal intubation, fresh gas flow will be applied at 4 lt/min for 8 minutes, reduced to 0.5 lt/min in Group L, 2 lt/min in Group M, and maintained at 4 lt/min in Group H. After extubation, patients will be monitored in the recovery unit for at least 30 minutes, and at postoperative 0th minute (when first seen in the recovery room), 30th minute, 1st hour, 6th hour, 12th hour and 24th hour, the nausea score of the patients will be evaluated using the Numerical Rating Scale (NRS) with a score between 0 and 10. If vomiting is present, the number of times the patient vomited will be questioned and recorded. The patients' postoperative VAS scores, the amount of antiemetics used, the amount of opioids used intraoperatively and postoperatively will be recorded, and comparisons will be made between the groups and evaluated.

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.
Interventional

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.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Adıyaman, Merkez, Turkey (Türkiye), 02040
        • Adıyaman Training and Research 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who agreed to participate in the study
  • 18-65 years of age
  • ASA I-II risk group patients

Exclusion Criteria:

  • Patient does not accept the study
  • Presence of psychiatric disorder and patient's inability to cooperate
  • Cognitive dysfunction
  • Hearing problems
  • History of alcohol or drug addiction
  • Presence of a serious pre-existing medical condition that limits objective assessment
  • Complications developed during surgery
  • Presence of any life-threatening condition after surgery
  • Patient's classification is ASA III-IV

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: low flow anesthesia group
After endotracheal intubation, fresh gas flow will be applied at 4 lt/min for 8 minutes, and in the low-flow anesthesia group, it will be reduced to 0.5 lt/min and maintained at this flow throughout the surgery.
Other: 0.5 lt/dk fresh gas flow
Fresh gas flow will be set to 0.5 l/min in the low flow anesthesia group.
Active Comparator: medium flow anesthesia group
After endotracheal intubation, fresh gas flow will be applied at 4 lt/min for 8 minutes, and in the medium-flow anesthesia group, it will be reduced to 2 lt/min and maintained at this flow throughout the surgery.
Other: 2 lt/dk fresh gas flow
Fresh gas flow will be set to 2 lt/min in the medium flow anesthesia group.
Active Comparator: high flow anesthesia group
After endotracheal intubation, fresh gas flow will be applied at 4 lt/min for 8 minutes and then continued in the same manner (4 lt/min) in the high-flow anesthesia group.
Other: 4 lt/dk fresh gas flow
Fresh gas flow will be set to 4 lt/min in the high flow anesthesia 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: 24 hours
The patients' postoperative nausea and vomiting scores will be assessed when they are taken to the postoperative care room, immediately before being transferred from the postoperative care room to the ward (at the 30th minute postoperatively), at the 1st hour postoperatively, at the 6th hour postoperatively, at the 12th hour postoperatively, and at the 24th hour postoperatively. Nausea will be assessed by scoring with a numerical rating scale between 0 and 10. Vomiting will be questioned. If vomiting occurs, the number of times it occurs will be questioned. Whether postoperative antiemetics are used and if so, how many mg are used will be recorded. If postoperative opioids are used, how many mg are used will be recorded.
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
intraoperative body temperature
Time Frame: intraoperative
Intraoperative body temperature values of patients in all groups will be monitored throughout the operation with a thermometer probe placed under the right armpit; axillary body temperature will be recorded every 5 minutes in the first half hour, 10 minutes in the next half hour, and every half hour after the first hour. Body temperature changes of the groups will also be compared.
intraoperative
Whether kidney functions are affected
Time Frame: 1 hour postoperative
By comparing the kidney function tests (urea-creatinine) of the patients before and after the surgery (postoperative 1st hour), it will be evaluated whether the flow differences (especially low flow) have any negative effects on kidney functions.
1 hour postoperative
whether liver functions are affected
Time Frame: 1 hour postoperative
Patients' liver function tests (AST-ALT) before and after surgery (postoperative 1st hour) will be compared to evaluate whether flow differences (especially low flow) have any negative effects on liver functions.
1 hour postoperative

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.
Adiyaman University Research Hospital

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.
March 10, 2025

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.
September 28, 2025

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.
September 30, 2025

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).
April 14, 2025

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 29, 2025

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.
May 1, 2025

Study Record Updates

Last Update Posted (Estimated)

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.
January 14, 2026

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.
January 13, 2026

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.
January 1, 2026

More Information

Terms related to this study

Keywords

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.
  • AURH-AR-UK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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