NCT06952946

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

April 14, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

fresh gas flowlow flow anesthesiapostoperative nausea vomiting

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (3)

  • intraoperative body temperature

    intraoperative

  • Whether kidney functions are affected

    1 hour postoperative

  • whether liver functions are affected

    1 hour postoperative

Study Arms (3)

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.

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.

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.

Other: 4 lt/dk fresh gas flow

Interventions

Fresh gas flow will be set to 0.5 l/min in the low flow anesthesia group.

low flow anesthesia group

Fresh gas flow will be set to 2 lt/min in the medium flow anesthesia group.

medium flow anesthesia group

Fresh gas flow will be set to 4 lt/min in the high flow anesthesia group.

high flow anesthesia group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman Training and Research Hospital

Adıyaman, Merkez, 02040, 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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Researchers who will evaluate postoperative nausea and vomiting and patients participating in the study will be blinded to the difference in fresh gas flow that will be applied to them.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist physician

Study Record Dates

First Submitted

April 14, 2025

First Posted

May 1, 2025

Study Start

March 10, 2025

Primary Completion

September 28, 2025

Study Completion

September 30, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations