- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465146
Effects of Minimal and Metabolic Flow Sevoflurane Anesthesia in Gynecological Surgery Patients
Comparative Analysis of Sevoflurane-Based Minimal and Metabolic Flow Anaesthesia: A Prospective Randomized Study in a Gynecological Surgery Patient Cohort
The aim of this study is to observe the effects of minimal and metabolically required basal anesthetic gas flow rates delivered by the anesthesia workstation under general anesthesia on body temperature, blood pressure, and heart rate during surgery.
It also aims to evaluate the impact of reducing excessive delivery of anesthetic gases, air, and oxygen beyond the patient's physiological needs during general anesthesia on minimizing the harmful effects of anesthetic gases on the environment, climate, and global warming, as well as on contributing positively to hospital costs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized study will be conducted in adult female patients undergoing elective gynecological surgery under general anesthesia. Following standard intravenous induction and endotracheal intubation, anesthesia will be maintained with sevoflurane using an advanced anesthesia workstation capable of delivering minimal and metabolic fresh gas flow rates.
After achieving the target anesthetic depth guided by minimum alveolar concentration (MAC) and MAC Brain monitoring, patients will be randomized to receive either minimal-flow (0.5 L/min) or metabolic-flow (0.3 L/min) fresh gas anesthesia. Randomization will be performed using an internet-based randomization tool.
Standard intraoperative monitoring will be applied in all patients, including electrocardiography, non-invasive blood pressure monitoring, pulse oximetry, capnography, anesthetic gas analysis, and esophageal temperature monitoring. Hemodynamic and respiratory parameters will be recorded at predefined time intervals throughout surgery. Sevoflurane consumption will be automatically calculated by the anesthesia workstation.
At the end of surgery, fresh gas flow will be increased to eliminate residual anesthetic gases, and patients will be extubated according to standard clinical criteria. Postoperative monitoring will continue in the post-anesthesia care unit.
The total study duration for each participant includes the intraoperative period and approximately 30 minutes of postoperative monitoring.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06490
- Baskent University Ankara Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female patients aged 18-65 years
- Undergoing elective gynecologic surgery under general anesthesia (including hysterectomy and/or oophorectomy)
Exclusion Criteria:
- Pregnant patients
- Patients with advanced cardiac disease
- Patients with advanced renal disease
- Patients with advanced hepatic disease
- Patients with advanced respiratory disease
- Severe obesity
- Heavy smokers
- Excessive alcohol consumption
- Known allergic sensitivity to halogenated anesthetic gases
- Use of medications that may interact with volatile anesthetics
- History of or susceptibility to malignant hyperthermia or neuromuscular disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Minimal Flow Group (0.5 L/min)
Participants will receive general anesthesia maintained with sevoflurane at a fresh gas flow rate of 0.5 L/min (minimal flow) after induction and achievement of target anesthetic concentration.
Standard monitoring will be applied throughout surgery, including hemodynamic and respiratory parameters.
|
Adjustment of fresh gas flow rates during general anesthesia using a modern anesthesia workstation (Getinge Flow-C).
Patients will be randomized to receive anesthesia with either minimal flow (0.5 L/min) or metabolic flow (0.3 L/min).
All other anesthetic agents and monitoring parameters will remain standardized according to institutional protocols.
Other Names:
|
|
Metabolic Flow Group (0.3 L/min)
Participants will receive general anesthesia maintained with sevoflurane at a fresh gas flow rate of 0.3 L/min (metabolic flow) after induction and achievement of target anesthetic concentration.
Standard intraoperative monitoring will be applied as in the minimal flow group.
|
Adjustment of fresh gas flow rates during general anesthesia using a modern anesthesia workstation (Getinge Flow-C).
Patients will be randomized to receive anesthesia with either minimal flow (0.5 L/min) or metabolic flow (0.3 L/min).
All other anesthetic agents and monitoring parameters will remain standardized according to institutional protocols.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core body temperature (°C)
Time Frame: From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
Mean intraoperative core body temperature (Degrees Celsius (°C)): Measured intraoperatively using an esophageal temperature probe. |
From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
|
Mean intraoperative heart rate (bpm)
Time Frame: From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
Mean intraoperative heart rate (Beats per minute (bpm)): Measured intraoperatively via electrocardiographic monitoring.
|
From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
|
Mean intraoperative mean arterial pressure (mmHg)
Time Frame: From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
Mean intraoperative mean arterial pressure (Millimeters of mercury (mmHg)): Measured intraoperatively using non-invasive blood pressure monitoring.
|
From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
|
Anesthetic gas consumption (mL)
Time Frame: From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
Total sevoflurane consumption (Milliliters (mL)): As recorded by the anesthesia workstation.
|
From induction of anesthesia until the end of surgery (approximately 1-2 hours)
|
|
Richmond Agitation-Sedation Scale (RASS) (-5 to 4)
Time Frame: At the end of surgery / immediate postoperative period
|
Richmond Agitation-Sedation Scale (RASS) (-5 to 4): The RASS is a 10-point scale ranging from -5 to +4.
Negative scores (-1 to -5) indicate increasing levels of sedation, with -5 indicating an unarousable patient.
Positive scores (+1 to +4) indicate increasing levels of agitation, with +4 indicating combative behavior.
Scores closer to 0 reflect better recovery quality.
|
At the end of surgery / immediate postoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anesthetic gas cost (USD or local currency)
Time Frame: Intraoperative period - calculated at the end of surgery (1-2 hours).
|
Total intraoperative anesthetic gas cost (USD or local currency): Calculated based on total sevoflurane consumption recorded by the anesthesia workstation. |
Intraoperative period - calculated at the end of surgery (1-2 hours).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asude Ayhan, MD, Baskent University Ankara Hospital, Department of Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- KA 24/235
- Baskent University (Other Identifier: Baskent University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Low-flow Anesthesia
-
Başakşehir Çam & Sakura City HospitalRecruitingLow Flow Anesthesia | High Flow AnesthesiaTurkey
-
Ankara City Hospital BilkentCompletedRobotic Surgery | Low Flow Anesthesia | Normal Flow AnesthesiaTurkey (Türkiye)
-
Erzincan Binali Yildirim UniversitesiActive, not recruitingLow Flow AnesthesiaTurkey (Türkiye)
-
University of GaziantepCompleted
-
Ankara City Hospital BilkentNot yet recruitingLow Flow Anesthesia | Minimal Flow Anesthesia | Robotic Assisted Laparoscopic Abdominal SurgeryTurkey
-
Fundación Pública Andaluza para la gestión de la...CompletedSevoflurane | Desflurane | Anesthesia | Low Flow AnesthesiaSpain
-
University of GaziantepCompletedThe Effects of Sevoflurane and Desflurane Used in Low-Flow Anesthesia on Thiol Disulfide HomeostasisLow Flow AnesthesiaTurkey
-
Ondokuz Mayıs UniversityCompleted
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...Ankara Etlik City HospitalCompletedCardiac Surgery | Low Flow Anesthesia | Sevoflurane AnesthesiaTurkey (Türkiye)
-
Eda KAZANÇ ÖZDENCompletedMyringoplasty | Low-flow Anesthesia | Neutrophil-to-Lymphocyte Ratio | Tympanoplasty | High-flow AnesthesiaTurkey
Clinical Trials on Low Flow Anesthesia
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...Ankara Etlik City HospitalCompletedCardiac Surgery | Low Flow Anesthesia | Sevoflurane AnesthesiaTurkey (Türkiye)
-
Istanbul UniversityNot yet recruitingAnesthesia | Cardiac Arrhythmia
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalCompletedSevoflurane | Urolithiasis | Inhalational Anesthesia | Anesthesia Depth Monitoring | Retrograde Intrarenal Surgery (RIRS) | Minimal-flow Anesthesia | Anesthetic ConsumptionTurkey (Türkiye)
-
Kahramanmaras Sutcu Imam UniversityCompletedLow Flow Anesthesia | Volatile Anesthetic ConsumptionTurkey
-
Başakşehir Çam & Sakura City HospitalNot yet recruiting
-
Erzincan Binali Yildirim UniversitesiActive, not recruitingLow Flow AnesthesiaTurkey (Türkiye)
-
Navy General Hospital, BeijingCompletedFetal Distress | Oxygen Inhalation Therapy | Second Stage of LabourChina
-
The University of Texas Health Science Center,...Not yet recruitingAirway DisorderUnited States
-
Inonu UniversityCompletedEmergence Agitation | Rhinoplasty | AnestheticsTurkey
-
M.D. Anderson Cancer CenterCompleted