Anesthesia, General
Conditions
Keywords
Sevoflurane, Desflurane, Low-flow anesthesia
Brief summary
This randomized, double-blind, controlled clinical trial aims to compare the effects of low-flow sevoflurane and desflurane anesthesia on physiological parameters and recovery profiles in adult patients undergoing ENT surgeries. The primary outcomes include heart rate, mean arterial pressure, peripheral oxygen saturation, end-tidal CO₂, and arterial blood gas values. Secondary outcomes involve time to spontaneous respiration, extubation, and response to verbal commands.
Detailed description
This prospective study investigates the clinical effects of low-flow anesthesia using two commonly utilized volatile agents, sevoflurane and desflurane, in adult patients undergoing elective ENT surgeries, specifically rhinoplasty, mastoidectomy, and tympanoplasty. A total of 40 ASA I-II patients, aged 18-65, will be randomly assigned into two groups: Group S (sevoflurane) and Group D (desflurane). All participants will undergo general anesthesia with endotracheal intubation. After 2 minutes of preoxygenation with 100% oxygen at 10 L/min, anesthesia will be induced and maintained with the assigned volatile agent under low-flow settings (1 L/min, 50% O₂-50% air). Hemodynamic and respiratory parameters (HR, MAP, SpO₂, EtCO₂) will be recorded at predefined time points, along with arterial blood gas analysis (pH, pCO₂, pO₂, COHb). Recovery times including return of spontaneous respiration, extubation, and verbal response will be documented. This study aims to provide clinical evidence on the optimal anesthetic choice under low-flow conditions, supporting safer, more efficient, and environmentally conscious anesthesia practices.
Interventions
DRUGSevoflurane
Sevoflurane will be administered via inhalation under low-flow anesthesia conditions. The concentration will be maintained at 2-3% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen and 50% air) after induction. Used in Group S (Sevoflurane Low-Flow Anesthesia Arm).
DRUGDesflurane
Desflurane will be administered via inhalation under low-flow anesthesia conditions. The concentration will be maintained at 4-6% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen and 50% air) after induction. Used in Group D (Desflurane Low-Flow Anesthesia Arm).
Sponsors
Harran University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Both participants and outcome assessors will be blinded to group allocation. Anesthesia providers will use coded gas assignments to ensure blinding during the intervention.
Intervention model description
Participants will be randomly assigned to receive either low-flow sevoflurane or low-flow desflurane anesthesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged between 18 and 65 years * Classified as ASA physical status I or II * Scheduled to undergo elective ENT surgery (rhinoplasty, mastoidectomy, or tympanoplasty) * Requiring general anesthesia with endotracheal intubation * Providing written informed consent
Exclusion criteria
* ASA physical status III or higher * History of malignant hyperthermia or delayed emergence from anesthesia * Morbid obesity (BMI ≥ 35) * Coronary artery disease, congestive heart failure, COPD, liver or kidney disease * Pregnancy or breastfeeding * Allergy to halogenated anesthetics * Respiratory pathology * Substance or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate During Surgery | From preoperative baseline to 120 minutes after anesthesia induction | Heart rate (HR) will be measured at baseline, post-intubation, and at 15, 30, 45, 60, and 120 minutes after anesthesia induction. |
| Change in Mean Arterial Pressure During Surgery | From preoperative baseline to 120 minutes after induction | Mean arterial pressure (MAP) will be recorded at the same predefined time intervals during surgery. |
| Change in End-Tidal CO₂ | From preoperative baseline to 120 minutes after induction | End-tidal carbon dioxide (EtCO₂) levels will be monitored during surgery at specified intervals. |
| Change in Peripheral Oxygen Saturation | From preoperative baseline to 120 minutes after induction | Peripheral oxygen saturation (SpO₂) will be measured at baseline, post-intubation, and intraoperative time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arterial pH | Preoperative, intraoperative (60 and 120 min), end of surgery | Arterial blood gas samples will be analyzed for pH at baseline, 60 and 120 minutes, and at end of surgery. |
| Post-Anesthesia Recovery Times | From end of surgery until recovery (within approx. 30 minutes) | Time to return of spontaneous respiration, time to extubation, and time to follow verbal commands will be recorded. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORBasak Pehlivan, Asoc Prof. Dr
Harran University
Outcome results
None listed