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

NCT07016308 | Completed

• 1 other identifier: Ceren
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General

Keywords

Sevoflurane; Desflurane; Low-flow anesthesia

Outcome Measures

Primary Outcomes (4)

• Change in Heart Rate During Surgery

  Heart rate (HR) will be measured at baseline, post-intubation, and at 15, 30, 45, 60, and 120 minutes after anesthesia induction.

  From preoperative baseline to 120 minutes after anesthesia induction

• Change in Mean Arterial Pressure During Surgery

  Mean arterial pressure (MAP) will be recorded at the same predefined time intervals during surgery.

  From preoperative baseline to 120 minutes after induction

• Change in End-Tidal CO₂

  End-tidal carbon dioxide (EtCO₂) levels will be monitored during surgery at specified intervals.

  From preoperative baseline to 120 minutes after induction

• Change in Peripheral Oxygen Saturation

  Peripheral oxygen saturation (SpO₂) will be measured at baseline, post-intubation, and intraoperative time points.

  From preoperative baseline to 120 minutes after induction

Secondary Outcomes (2)

• Change in Arterial pH

  Preoperative, intraoperative (60 and 120 min), end of surgery

• Post-Anesthesia Recovery Times

  From end of surgery until recovery (within approx. 30 minutes)

Study Arms (2)

Sevoflurane Low-Flow Anesthesia

EXPERIMENTAL

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.

Drug: Sevoflurane; Drug: Desflurane

Desflurane Low-Flow Anesthesia

ACTIVE COMPARATOR

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.

Drug: Sevoflurane; Drug: Desflurane

Interventions

Sevoflurane 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 Low-Flow Anesthesia; Sevoflurane Low-Flow Anesthesia

Desflurane 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).

Also known as: Suprane

Desflurane Low-Flow Anesthesia; Sevoflurane Low-Flow Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Veli Fahri Pehlivan

Sanliurfa, 63100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sevoflurane; Desflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Study Officials

• Basak Pehlivan, Asoc Prof. Dr

  Harran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both participants and outcome assessors will be blinded to group allocation. Anesthesia providers will use coded gas assignments to ensure blinding during the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to receive either low-flow sevoflurane or low-flow desflurane anesthesia.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 11, 2025
• Study Start: June 10, 2025
• Primary Completion: November 19, 2025
• Study Completion: December 15, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)