Gynecologic SurgeryNCT07506798
Impact of Combined Intravenous-Inhalational vs Inhalational Anesthesia on QoR-15 Recovery Scores in Gynecologic Surgery
A study testing Combined Intravenous-Inhalational Anesthesia and Inhalational Anesthesia Only in people with Gynecologic Surgery and Postoperative Recovery, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gynecologic Surgery, Postoperative Recovery, Anesthesia
- What is being tested?
- Combined Intravenous-Inhalational Anesthesia and Inhalational Anesthesia Only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University Training and Research Hospital
Sakarya, 54290
ayça taş tuna, Professor, 905323004826, aycatas@yahoo.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Gynecologic Surgery, Postoperative Recovery, Anesthesia
- Being tested
- Combined Intravenous-Inhalational Anesthesia, Inhalational Anesthesia Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Intravenous-Inhalational AnesthesiaDrug
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.
Inhalational Anesthesia OnlyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Inhalational Anesthesia Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 1 and Postoperative Day 2
Secondary outcomes (3)
Postoperative pain score
Pain will be assessed using a standard numerical rating scale (0-10) at postoperative hours 6, 12, and 24. Higher scores indicate more pain.
Measured: Postoperative hours 6, 12, and 24
Postoperative nausea and vomiting (PONV) incidence
Incidence of nausea and vomiting will be recorded in the first 24 hours after surgery.
Measured: Postoperative hours 0-24
Length of stay in post-anesthesia care unit (PACU)
Duration of stay in PACU will be recorded in minutes from admission to discharge.
Measured: Postoperative period (PACU stay), assessed up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, melike kar, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506798
- Sponsor's protocol ID
- E.513181 (Application No: 473)
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Intravenous-Inhalational Anesthesia Versus Inhalational Anesthesia on Postoperative Recovery in Gynecological Operations: A Comparison Based on QoR-15 Scores
- ClinicalTrials.gov ID
- NCT07506798
- Acronym / sponsor ID
- E.513181 (Application No: 473)
- Conditions
- Gynecologic Surgery, Postoperative Recovery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Apr 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined Intravenous-Inhalational Anesthesia | Experimental | Drug: Combined Intravenous-Inhalational AnesthesiaPatients 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. |
| Inhalational Anesthesia Only | Active comparator | Drug: Inhalational Anesthesia OnlyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Combined Intravenous-Inhalational AnesthesiaPatients 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. | Drug | Combined Intravenous-Inhalational Anesthesia |
| Inhalational Anesthesia OnlyPatients 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. | Drug | Inhalational Anesthesia Only |
Primary outcome
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.
3 secondary outcomes
Postoperative pain score
Time frame: Postoperative hours 6, 12, and 24
Postoperative nausea and vomiting (PONV) incidence
Time frame: Postoperative hours 0-24
Length of stay in post-anesthesia care unit (PACU)
Time frame: Postoperative period (PACU stay), assessed up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gynecologic Surgery
Active, not recruiting
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Gynecologic Surgery
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Enrolling by invitation
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
Gynecologic Surgery, General Anesthesia
Active, not recruiting
SORE Study: Sitz Baths After Urogynecologic Reconstruction
Pelvic Organ Prolapse, Postoperative Pain Management
Recruiting
Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Gynecologic Surgery
ERAS, Gynecologic Surgery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Intravenous-Inhalational Anesthesia and Inhalational Anesthesia Only in people with Gynecologic Surgery and Postoperative Recovery, run by Sakarya University 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact melike kar ünlü, MD (905079790381, Melikekar2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recovery using QoR-15 (time frame: Postoperative Day 1 and Postoperative Day 2). 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 2 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.