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Completed

NCT Number: NCT07016308

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veli Fahri Pehlivan

Sanliurfa, 63100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

Other names: Suprane

Primary outcomes

  1. Change in Heart Rate During Surgery

    Time frame: 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.

  2. Change in Mean Arterial Pressure During Surgery

    Time frame: From preoperative baseline to 120 minutes after induction

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

  3. Change in End-Tidal CO₂

    Time frame: From preoperative baseline to 120 minutes after induction

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

  4. Change in Peripheral Oxygen Saturation

    Time frame: From preoperative baseline to 120 minutes after induction

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

Secondary outcomes

  1. Change in Arterial pH

    Time frame: 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.

  2. Post-Anesthesia Recovery Times

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

Effects of Low-Flow Desflurane and Sevoflurane Anesthesia on Physiological Parameters and Recovery Process

Acronym: LoFADS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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