- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06952946
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
150
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
Fresh gas flow will be set to 4 lt/min in the high flow anesthesia group.
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
March 10, 2025
Primary Completion (Actual)
September 28, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
April 14, 2025
First Submitted That Met QC Criteria
April 29, 2025
First Posted (Actual)
May 1, 2025
Study Record Updates
Last Update Posted (Estimated)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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