Clinical trial NCT07016308: Low-Flow Desflurane vs Sevoflurane: Impact on Physiology and Recoveryand Recovery Profiles in Adult ENT Surgery
Official title: Effects of Low-Flow Desflurane and Sevoflurane Anesthesia on Physiological Parameters and Recovery Process
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia, General
Keywords: Sevoflurane
Desflurane
Low-flow anesthesia
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive either low-flow sevoflurane or low-flow desflurane anesthesia.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Heart Rate During Surgery
timeFrame: From preoperative baseline to 120 minutes after anesthesia induction
measure: Change in Mean Arterial Pressure During Surgery
timeFrame: From preoperative baseline to 120 minutes after induction
measure: Change in End-Tidal CO₂
timeFrame: From preoperative baseline to 120 minutes after induction
measure: Change in Peripheral Oxygen Saturation
timeFrame: From preoperative baseline to 120 minutes after induction
Secondary outcomes:
measure: Change in Arterial pH
timeFrame: Preoperative, intraoperative (60 and 120 min), end of surgery
measure: Post-Anesthesia Recovery Times
timeFrame: From end of surgery until recovery (within approx. 30 minutes)
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Veli Fahri Pehlivan
Study officials:
affiliation: Harran University
name: Basak Pehlivan, Asoc Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: