Efficacy of an Intravenous Dose of Propofol Versus Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane)
研究概览
简要总结
Emergence of general anesthesia is a critical period, in the same way as the induction of anesthesia, during which several adverse events may occur. Extubation may even be more difficult than the intubation, with a higher respiratory complications rate. Among these, cough is common and expected. It can be associated with significant complications including hypertension, tachycardia, increased intracranial pressure, bleeding at the surgical site or even wound dehiscence.
The incidence of coughing during emergence of general anesthesia varies depending on the type of airway instrumentation, the population under study, agents used for the maintenance of the anesthesia and techniques used to prevent coughing. In the literature, the incidence of coughing during emergence of general anesthesia under endotracheal intubation varies from 38 to 96%. In our center, the incidence of coughing during emergence of general anesthesia under desflurane and endotracheal intubation is 30 % according to a local preliminary study.
Propofol is well-known to inhibit airway reflexes. Total intravenous anesthesia (TIVA) is associated with a lower incidence of coughing compared to inhalated anesthesia. The efficacy of propofol at a subhypnotic dose to reduce coughing during emergence has recently been demonstrated in patients undergoing nasal surgery under sevoflurane. However, the most effective antitussive dose remains unknown and its efficacy during anesthesia under desflurane has not yet been demonstrated.
Propofol is rapidly available, simple to administer and has an interesting pharmacological profile, among others due to its short half-life.
The aim of this study is to evaluate if an intravenous bolus of 0.5 mg/kg of propofol is more effective than placebo administration to decrease the incidence of coughing during emergence of general anesthesia under desflurane (PROPOREV). Propofol could also reduce the incidence of postoperative nausea and vomiting (PONV).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged between 18 to 80 years undergoing elective surgery under general anesthesia with an orotracheal intubation;
- •Patients of American Society of Anesthesiologists (ASA) I to III inclusively at the preoperative evaluation
- •Patients affiliated to a medical insurance system.
排除标准
- •Ear, nose and throat (ENT) surgery, thoracic and neurological surgery ;
- •Participation refusal;
- •Patient allergic to or presenting a contraindication to propofol;
- •Patient with a tracheostomy;
- •Chronic coughing, i.e. daily cough for 8 weeks or more;
- •Asthma / severe or exacerbated chronic obstructive pulmonary disease (COPD);
- •Recent respiratory tracts infection (< 4 weeks);
- •Hemostasis disorders;
- •Patient known for a non-secure cerebral aneurysm;
- •Patient known for a difficult intubation (grade 3 or 4);
- •Patient suffering from mental, neurological, or severe cardiovascular disease;
- •Pregnant or breastfeeding women;
- •Patients with deafness and/or unable to have conversations in a normal voice;
- •Patient with language barrier (not speaking French, nor English);
- •Patient suffering from dementia or patient under guardianship.
研究组 & 干预措施
Propofol
Active drug given to patients as an intravenous dose of 0.5 mg/kg of propofol
干预措施: Intravenous dose of 0.5 mg/kg of propofol (Drug)
Saline solution
Placebo drug given to patients as an intravenous dose of 0.05 mL/kg of saline solution (NaCl 0.9%)
干预措施: Intravenous dose of 0.05 mL/kg of saline solution (Drug)
结局指标
主要结局
Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane)
时间窗: one day, perioperative period
Incidence of coughing during emergence of general anesthesia (between discontinuation of desflurane and MAC of 0.15 of desflurane) and its severity based on a 4-grade scale
次要结局
- Incidence of hypoventilation(one day, perioperative period)
- Incidence of hypoxic episode(one day, perioperative period)
- Blood pressure(one day, perioperative period)
- Heart rate(one day, perioperative period)
- Agitation of the patient during emergence(one day, perioperative period)
- Complications(one day, perioperative period)
- Incidence of coughing (between discontinuation of desflurane, MAC of 0.1 and 0.2 of desflurane, at extubation, as well as 5 and 10 min after extubation)(one day, perioperative period)
- Extubation time(one day, perioperative period)
- Sedation of the patient(one day, perioperative period)
- Cumulative incidence of nausea/vomiting(one day, perioperative period)
- Swallowing pain scores(one day, perioperative period)