- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506798
Impact of Combined Intravenous-Inhalational vs Inhalational Anesthesia on QoR-15 Recovery Scores in Gynecologic Surgery
Effects of Combined Intravenous-Inhalational Anesthesia Versus Inhalational Anesthesia on Postoperative Recovery in Gynecological Operations: A Comparison Based on QoR-15 Scores
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: melike kar ünlü, MD
- Phone Number: 905079790381
- Email: Melikekar2015@gmail.com
Study Locations
-
-
-
Sakarya, Turkey (Türkiye), 54290
- Recruiting
- Sakarya University Training and Research Hospital
-
Contact:
- ayça taş tuna, Professor
- Phone Number: 905323004826
- Email: aycatas@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combined Intravenous-Inhalational Anesthesia
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.
|
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.
|
|
Active Comparator: Inhalational Anesthesia Only
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative recovery using QoR-15
Time Frame: Postoperative Day 1 and Postoperative Day 2
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain score
Time Frame: Postoperative hours 6, 12, and 24
|
Pain will be assessed using a standard numerical rating scale (0-10) at postoperative hours 6, 12, and 24.
Higher scores indicate more pain.
|
Postoperative hours 6, 12, and 24
|
|
Postoperative nausea and vomiting (PONV) incidence
Time Frame: Postoperative hours 0-24
|
Incidence of nausea and vomiting will be recorded in the first 24 hours after surgery.
|
Postoperative hours 0-24
|
|
Length of stay in post-anesthesia care unit (PACU)
Time Frame: Postoperative period (PACU stay), assessed up to 10 days
|
Duration of stay in PACU will be recorded in minutes from admission to discharge.
|
Postoperative period (PACU stay), assessed up to 10 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E.513181 (Application No: 473)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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