Low-Flow Desflurane vs Sevoflurane: Impact on Physiology and Recoveryand Recovery Profiles in Adult ENT Surgery

NCT ID: NCT07016308

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to receive either low-flow sevoflurane or low-flow desflurane anesthesia.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Both participants and outcome assessors will be blinded to group allocation. Anesthesia providers will use coded gas assignments to ensure blinding during the intervention.

Study Groups

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Sevoflurane Low-Flow Anesthesia

Participants in this group will receive general anesthesia using sevoflurane administered under low-flow conditions. After standard induction and intubation, sevoflurane will be maintained at 2-3% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen / 50% air). Vital signs and arterial blood gases will be monitored, and recovery parameters such as time to spontaneous breathing, extubation, and verbal response will be recorded.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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).

Desflurane

Intervention Type DRUG

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).

Desflurane Low-Flow Anesthesia

Participants in this group will receive general anesthesia using desflurane administered under low-flow conditions. After standard induction and intubation, desflurane will be maintained at 4-6% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen / 50% air). Hemodynamic and respiratory parameters as well as arterial blood gases and recovery times will be evaluated and compared to the sevoflurane group.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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).

Desflurane

Intervention Type DRUG

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).

Interventions

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Sevoflurane

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).

Intervention Type DRUG

Desflurane

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).

Intervention Type DRUG

Other Intervention Names

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Suprane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harran University

OTHER

Sponsor Role lead

Responsible Party

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Veli Fahri Pehlivan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basak Pehlivan, Asoc Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

Harran University

Locations

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Veli Fahri Pehlivan

Sanliurfa, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Başak Pehlivan, Asoc Prof. Dr

Role: CONTACT

+905054083194

Merve C Ercan, Dr

Role: CONTACT

+905522951407

Facility Contacts

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Veli Fahri Pehlivan, Asisst Prof

Role: primary

05327696566

Other Identifiers

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Ceren

Identifier Type: -

Identifier Source: org_study_id

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