Effects of Low-Flow Desflurane and Sevoflurane Anesthesia on Physiological Parameters and Recovery Process
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Heart Rate During Surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Both participants and outcome assessors will be blinded to group allocation. Anesthesia providers will use coded gas assignments to ensure blinding during the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sevoflurane (Drug)
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.
干预措施: Desflurane (Drug)
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.
干预措施: Sevoflurane (Drug)
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.
干预措施: Desflurane (Drug)
结局指标
主要结局
Change in Heart Rate During Surgery
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From preoperative baseline to 120 minutes after induction
Peripheral oxygen saturation (SpO₂) will be measured at baseline, post-intubation, and intraoperative time points.
次要结局
- 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))
研究者
Veli Fahri Pehlivan
Assistant Professor
Harran University