The Effect of Low-Flow Sevoflurane and Low-Flow Desflurane Anesthesia on Postoperative Sore Throat in Laparoscopic Cholecystectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Presence and Severity of Postoperative Sore Throat
研究概览
简要总结
Several studies have demonstrated that inhalational anesthetic agents such as desflurane and sevoflurane may cause varying degrees of postoperative sore throat, hoarseness, and cough in orotracheally intubated patients. However, data evaluating these outcomes under low-flow anesthesia conditions remain limited and insufficient.
This single-center, prospective, randomized controlled study will be conducted in patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-II, who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia and who provide written informed consent to participate in the study.
The primary objective of the study is to compare the effects of low-flow desflurane and low-flow sevoflurane anesthesia on the incidence and severity of postoperative sore throat.
The secondary outcomes include the evaluation of postoperative hoarseness and cough, the incidence of postoperative nausea and vomiting (PONV), and the total consumption of inhalational anesthetic agents.
详细描述
Postoperative sore throat (POST) is a common complaint occurring after extubation, with a reported incidence of 14-62%, and is primarily caused by mucosal irritation or injury related to orotracheal intubation and airway manipulation. Cough and hoarseness are also frequently observed complications following tracheal intubation and may negatively affect patient comfort; the incidence of these symptoms has been reported in the literature to range widely from 7% to 90%. Female sex, inappropriate endotracheal tube size, high cuff pressure, airway management devices, and the anesthetic and neuromuscular blocking agents used are among the factors associated with POST.
Low-flow anesthesia offers several advantages, including reduced heat and humidity loss, preservation of mucociliary activity, and decreased environmental pollution and cost. However, it requires close monitoring due to potential risks such as hypoxemia, hypercapnia, and hemodynamic or anesthetic depth alterations related to insufficient or excessive anesthetic delivery. Although some studies have suggested that desflurane, due to its irritant properties, may have more adverse effects on sore throat and cough compared with sevoflurane, the number of studies comparing these two agents under low-flow anesthesia conditions remains limited.
In this study, cuff pressure was standardized within the range of 20-30 cmH₂O and endotracheal tube sizes were determined according to sex in order to minimize potential confounding effects related to tube size and cuff pressure.
The study will be conducted at Kayseri City Hospital to compare low-flow sevoflurane and low-flow desflurane anesthesia in patients aged 18-65 years, classified as ASA physical status I-II, who are scheduled for elective laparoscopic cholecystectomy under general anesthesia.
All patients will receive standard monitoring including electrocardiography (ECG), non-invasive blood pressure, peripheral oxygen saturation (SpO₂), and capnography. Depth of anesthesia will be monitored using the Bispectral Index (BIS), and neuromuscular blockade will be assessed with Train-of-Four (TOF) monitoring. Prior to induction, an anesthesia machine leak test will be performed and the CO₂ absorbent will be checked. A 20G intravenous line will be established and fluid infusion initiated. Induction will be achieved with fentanyl, lidocaine, propofol, and rocuronium. Orotracheal intubation will be performed using a Macintosh laryngoscope; cuffed endotracheal tubes with an internal diameter of 7.0-7.5 mm for females and 7.5-8.0 mm for males will be used. Cuff pressure will be maintained between 20-30 cmH₂O using a manometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Aged between 18 and 65 years
- •Patients who provide written informed consent to participate in the study
排除标准
- •Patients with a recent history of upper respiratory tract infection
- •Patients with a recent history of sore throat
- •Patients with chronic cough
- •Patients with a history of previous neck or tracheal surgery
- •Patients with predictors of difficult intubation
- •Patients with a history of difficult intubation
- •Obese patients (BMI > 35 kg/m²)
- •Patients with chronic respiratory diseases (asthma, COPD)
- •Pregnancy
- •Use of dexamethasone
- •Patients with hepatic impairment
- •Patients with allergy to paracetamol, tramadol, granisetron, dexamethasone, or metoclopramide
- •Patients with known allergy to halogenated anesthetic agents
- •Patients with a history of malignant hyperthermia
- •Patients with mental disorders or those unable to provide reliable assessment
研究组 & 干预措施
Low-Flow Desflurane Group
In the Low-Flow Desflurane Group (DD), a combination of 4 L/min fresh gas flow consisting of 50% O₂ and 50% air with 6% desflurane will be administered for the first 10 minutes. Thereafter, the fresh gas flow will be reduced to 1 L/min, and a mixture of 50% O₂ and 50% air with 7-8% desflurane will be administered.
The concentration of the inhalational anesthetic agent and the rate of remifentanil infusion will be titrated by the attending anesthesiologists to maintain the Bispectral Index (BIS) between 40 and 60, to keep the mean arterial pressure within ±20% of baseline values, and to achieve the age-adjusted minimum alveolar concentration (MAC).
干预措施: Desflurane (Drug)
Low-Flow Sevoflurane Group
In the Low-Flow Sevoflurane Group (DS), a combination of 4 L/min fresh gas flow consisting of 50% O₂ and 50% air with 2-3% sevoflurane will be administered during the first 10 minutes. Thereafter, the fresh gas flow will be reduced to 1 L/min, and a mixture of 50% O₂ and 50% air with 3-4% sevoflurane will be administered. The concentration of the inhalational anesthetic agents and the rate of remifentanil infusion will be titrated by the attending anesthesiologists to maintain the Bispectral Index (BIS) between 40 and 60, to keep the mean arterial pressure within ±20% of baseline values, and to achieve the age-adjusted minimum alveolar concentration (MAC).
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Presence and Severity of Postoperative Sore Throat
时间窗: 0, 2, 4, and 24 hours postoperatively
Presence (yes/no) and severity of postoperative sore throat assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at predefined postoperative time points.
Presence of Postoperative Sore Throat
时间窗: 0, 2, 4, and 24 hours postoperatively
Presence (yes/no) at predefined postoperative time points.
次要结局
- Postoperative hoarseness(0, 2, 4, and 24 hours postoperatively)
- Postoperative Cough(0, 2, 4, and 24 hours postoperatively)
- Postoperative Foreign Body Sensation in the Throat(0, 2, 4, and 24 hours postoperatively)
- Presence and Severity of Postoperative Nausea and Vomiting (PONV)(At postoperative 0, 2, 4, and 24 hours)
- Intraoperative Consumption of Inhalational Anesthetic Agents(Intraoperative period)
- Patient Satisfaction (5-Point Likert Scale)(24. hours postoperatively)
- Severity of Postoperative Sore Throat(0, 2, 4, and 24 hours postoperatively)
- Postoperative Dysphagia (Difficulty Swallowing)(0, 2, 4, and 24 hours postoperatively)
研究者
Emine Sümeyye Akköze
Research Assistant Doctor
Kayseri City Hospital