Nausea and Vomiting, PostoperativeNCT06952946
Effect of Fresh Gas Flow Differences on Postoperative Nausea and Vomiting
A study testing 0.5 lt/dk fresh gas flow, 2 lt/dk fresh gas flow and 4 lt/dk fresh gas flow in people with Nausea and Vomiting, Postoperative and Septoplasty/Septorhinoplasty, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nausea and Vomiting, Postoperative, Septoplasty/Septorhinoplasty
- What is being tested?
- 0.5 lt/dk fresh gas flow, 2 lt/dk fresh gas flow and 4 lt/dk fresh gas flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agreed to participate in the study
- 18-65 years of age
- ASA I-II risk group patients
Who cannot join
- 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
Show all 9Show fewer
- Complications developed during surgery
- Presence of any life-threatening condition after surgery
- Patient's classification is ASA III-IV
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman Training and Research Hospital
Adıyaman, Merkez, 02040
About this study
Official title: 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.
Read the 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.
- Being tested
- 0.5 lt/dk fresh gas flow, 2 lt/dk fresh gas flow, 4 lt/dk fresh gas flow
- Keywords
- fresh gas flow, low flow anesthesia, postoperative nausea vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 lt/dk fresh gas flowOther
Fresh gas flow will be set to 0.5 l/min in the low flow anesthesia group.
2 lt/dk fresh gas flowOther
Fresh gas flow will be set to 2 lt/min in the medium flow anesthesia group.
4 lt/dk fresh gas flowOther
Fresh gas flow will be set to 4 lt/min in the high flow anesthesia group.
| Study group | Role | What they receive |
|---|---|---|
| low flow anesthesia group | Active comparator | 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. Receives: Other: 0.5 lt/dk fresh gas flow |
| medium flow anesthesia group | Active comparator | 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. Receives: Other: 2 lt/dk fresh gas flow |
| high flow anesthesia group | Active comparator | 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. Receives: Other: 4 lt/dk fresh gas flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
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.
Measured: 24 hours
Secondary outcomes (3)
intraoperative body temperature
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.
Measured: intraoperative
Whether kidney functions are affected
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.
Measured: 1 hour postoperative
whether liver functions are affected
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.
Measured: 1 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start10 Mar 2025
- Primary completion28 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups to which fresh gas flow is applied as low flow (0.5 l/min), medium flow (2 l/min) and high flow (4 l/min).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Karbaş, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952946
- Sponsor's protocol ID
- AURH-AR-UK-01
- Status last verified
- Jan 2026
- First submitted
- 14 Apr 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Fresh Gas Flow Applications on Postoperative Nausea and Vomiting in Septorhinoplasty Surgeries
- ClinicalTrials.gov ID
- NCT06952946
- Acronym / sponsor ID
- AURH-AR-UK-01
- Keywords
- fresh gas flow, low flow anesthesia, postoperative nausea vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups to which fresh gas flow is applied as low flow (0.5 l/min), medium flow (2 l/min) and high flow (4 l/min).
| Arm | Type | Receives |
|---|---|---|
| low flow anesthesia group | Active comparator | Other: 0.5 lt/dk fresh gas flowAfter 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. |
| medium flow anesthesia group | Active comparator | Other: 2 lt/dk fresh gas flowAfter 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. |
| high flow anesthesia group | Active comparator | Other: 4 lt/dk fresh gas flowAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who agreed to participate in the study
- 18-65 years of age
- ASA I-II risk group patients
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 lt/dk fresh gas flowFresh gas flow will be set to 0.5 l/min in the low flow anesthesia group. | Other | low flow anesthesia group |
| 2 lt/dk fresh gas flowFresh gas flow will be set to 2 lt/min in the medium flow anesthesia group. | Other | medium flow anesthesia group |
| 4 lt/dk fresh gas flowFresh gas flow will be set to 4 lt/min in the high flow anesthesia group. | Other | high flow anesthesia group |
Primary outcome
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.
3 secondary outcomes
intraoperative body temperature
Time frame: intraoperative
Whether kidney functions are affected
Time frame: 1 hour postoperative
whether liver functions are affected
Time frame: 1 hour postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5 lt/dk fresh gas flow, 2 lt/dk fresh gas flow and 4 lt/dk fresh gas flow in people with Nausea and Vomiting, Postoperative and Septoplasty/Septorhinoplasty, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea and vomiting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.