NCT07506798

Brief Summary

This study aims to compare the effects of combined intravenous-inhalational anesthesia versus inhalational anesthesia alone on postoperative recovery in patients undergoing elective gynecologic surgery. A total of 100 patients, aged 18-65 years and classified as ASA I-III, scheduled for elective gynecologic procedures at Sakarya University Faculty of Medicine Training and Research Hospital, will be included. The sample size was calculated based on the primary outcome, the Quality of Recovery-15 (QoR-15) score. Patients will complete the QoR-15 questionnaire preoperatively, before knowing which anesthesia method will be applied. Postoperative QoR-15 scores will be collected on postoperative days 1 and 2, and intraoperative data will be obtained from anesthesia records. The study evaluates postoperative recovery using QoR-15 scores, covering physical comfort, emotional state, psychological support, pain, and ability to perform daily activities. Higher scores indicate better recovery, whereas lower scores indicate impaired postoperative recovery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2025Apr 2027

Study Start

First participant enrolled

October 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 14, 2026

Last Update Submit

March 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative recovery using QoR-15

    Postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated patient-reported outcome measure. The questionnaire evaluates physical comfort, emotional state, psychological support, pain, and ability to perform daily activities. Higher scores indicate better recovery.

    Postoperative Day 1 and Postoperative Day 2

Secondary Outcomes (3)

  • Postoperative pain score

    Postoperative hours 6, 12, and 24

  • Postoperative nausea and vomiting (PONV) incidence

    Postoperative hours 0-24

  • Length of stay in post-anesthesia care unit (PACU)

    Postoperative period (PACU stay), assessed up to 10 days

Study Arms (2)

Combined Intravenous-Inhalational Anesthesia

EXPERIMENTAL

Patients in this group will receive a combination of intravenous and inhalational anesthesia during elective gynecologic surgery. Postoperative recovery will be assessed using the QoR-15 questionnaire on postoperative days 1 and 2.

Drug: Combined Intravenous-Inhalational Anesthesia

Inhalational Anesthesia Only

ACTIVE COMPARATOR

Patients in this group will receive only inhalational anesthesia during elective gynecologic surgery. Postoperative recovery will be assessed using the QoR-15 questionnaire on postoperative days 1 and 2.

Drug: Inhalational Anesthesia Only

Interventions

Patients will receive a combination of intravenous anesthetic agents and inhalational anesthetic gases during elective gynecologic surgery. The specific anesthetic drugs and doses will follow routine clinical practice. Postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire on postoperative days 1 and 2.

Combined Intravenous-Inhalational Anesthesia

Patients will receive only inhalational anesthetic gases during elective gynecologic surgery, following routine clinical practice. Postoperative recovery will be assessed using the QoR-15 questionnaire on postoperative days 1 and 2.

Inhalational Anesthesia Only

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-65 years
  • Scheduled for elective gynecologic surgery at Sakarya University Faculty of Medicine Training and Research Hospital
  • Classified as ASA I-III
  • Able to understand and complete the QoR-15 questionnaire
  • Provided written informed consent

You may not qualify if:

  • Severe comorbidities (beyond ASA III)
  • Patients with advanced neurological disease or cognitive impairment
  • Known allergy to anesthetic drugs used in the study
  • Classified as ASA IV-V
  • Refusal to participate in the study
  • Emergency or urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

RECRUITING

Central Study Contacts

melike kar ünlü, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned in a parallel design to one of two groups: Combined intravenous-inhalational anesthesia group Inhalational anesthesia only group Each patient will receive only one anesthesia method during their elective gynecologic surgery. Outcomes will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire on postoperative days 1 and 2. This design allows a direct comparison of postoperative recovery between the two anesthesia methods.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 14, 2026

First Posted

April 2, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations