Optimal Remifentanil Site-effect Concentration for Preventing Severe Cough and Hyperdynamic Response During Tracheal Extubation After Sevoflurane vs. Desflurane. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Cough during emergency from anesthesia
研究概览
简要总结
Pain, cough, hypertension and tachycardia are frequent events during extubation due to a secondary stimulation of mechanoreceptors located in the airway. The mechanical effect of the endotracheal tube activates autonomic reflexes, a situation that could potentially impair the clinical condition of patients. Previous studies have used remifentanil during emergence and extubation showing good results to control this reflex response. However, it is unknown so far, the optimal effect site concentration (Ce) of remifentanil to allow a better control of these events with a low incidence of adverse effects after have received inhaled anesthesia plus remifentanil for anesthetic maintenance. This study will determine the Ce of remifentanil associated with a lower proportion of cough and hyperdynamic circulatory response during extubation for emergency after exposure to sevoflurane or desflurane.
详细描述
Single-center, randomized, double-blind protocol. The investigators aim to include 368 patients under balanced anesthesia with sevoflurane or desflurane to be randomly allocated into 6 different remifentanil Ce groups [77 individuals in each of interventional groups (2.0 vs. 2.5 ng/ml) and 30 in each of the control groups (1.0 ng/ml) administrated by a target-controlled infusion (TCI) system during emergence and tracheal extubation .
Once informed consent is obtained and inclusion/exclusion criteria are met, subjects will be randomized before starting of the surgical procedure. This information will remain blinded to the attendant anesthesiologist and the independent evaluator during the process of extubation, except for type of inhaled anesthetic for maintenance .
The intervention will start when the anesthesiologist decide to suspend the sevorane or desflurane dial. At this moment, the fresh flow gas of the anesthesia machine will be adjusted to 7-8 liters per minute and the infusion of remifentanil will be set up to establish a Ce of 2.0 ng/ml or 2.5 ng/ml. All patients will be extubated only when all of these three parameters exist: response to name by eyes opening, response to orders of breathing and mouth opening.
The evaluation and outcomes measurement will include: Presence and intensity of cough and changes in heart rate and blood pressure during eyes opening in response to calling by name, tracheal extubation and 2.5 min after, time to get to be extubated after inhaled anesthetic discontinuation, episodes of hypoxemia and sedation state during the first 25 minutes after extubation, requirements of rescue analgesia and postoperative nausea and vomit during this period.
Close monitoring of patients will take place and data will be collected during the preoperative, intraoperative and postoperative stages until discharge from the post anesthesia care unit. Lost to follow and adverse events will be assessed. An interim committee will evaluate partial results of the study when it reaches 25 and 50% of recruitment, so the investigators can continue building thereof according to analysis obtained.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesia status I and II
- •Age between 18 to 60 years.
- •Elective surgery.
排除标准
- •Uncontrolled hypertension. (SBP> 180 mmHg) at pre anesthesia area.
- •Active or uncontrolled pulmonary disease.
- •Signs or history of difficult airway.
- •Recent respiratory infection.
- •Train-of-four (TOF) index <90% at the end of surgery.
- •Patients who have received some form of pre oral medication.
- •Body mass Index above 30 kg/m
- •Concomitant use of epidural catheter.
- •Urgent surgery.
研究组 & 干预措施
Sevo-2.0
This group will maintain remifentanil infusion by TCI to 2 ng/ml during emergence and extubation after have received sevoflurane during procedure.
干预措施: Remifentanil (Drug)
Sevo-2.5
This group will maintain the remifentanil infusion by TCI to 2.5 ng/ml during emergence and tracheal extubation after have received sevoflurane during surgical procedure.
干预措施: Remifentanil (Drug)
Des-2.0
This group will maintain the remifentanil infusion by TCI to 2.0 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.
干预措施: Remifentanil (Drug)
Des-2.5
This group will maintain the remifentanil infusion by TCI to 2.5 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.
干预措施: Remifentanil (Drug)
Sevo-Control
This group will maintain the remifentanil infusion by TCI to 1.0 ng/ml during emergence and tracheal extubation after have received sevoflurane during surgical procedure.
干预措施: Remifentanil (Drug)
Des-Control
This group will maintain the remifentanil infusion by TCI to 1.0 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Cough during emergency from anesthesia
时间窗: From eye opening up to 2.5 minutes after tracheal extubation
Assess the presence and intensity of cough : 0) No cough, 1) A single episode of cough, 2) More than one episode of nonsustained cough, 3) sustained and repetitive cough with head elevation.
次要结局
- Halogenated end tidal concentration at tracheal extubation(From eyes opening until the event of tracheal extubation, assessed up to 20 minutes.)
- Cardiac response during emergence from anesthesia(From discontinuation of inhalational anesthetics up to 2.5 minutes after tracheal extubation)
- Time to tracheal extubation(From inhaled anesthetic discontinuation until the event of tracheal extubation, assessed up to 20 minutes.)
- Pressor response during emergence from anesthesia(From discontinuation of inhalational anesthetics up to 2.5 minutes post-extubation)
- Time to eye opening(From inhaled anesthetic discontinuation until the moment of eye opening response to verbal command (calling by name), assessed up to 20 minutes.)
- Respiratory rate during post-extubation(From tracheal extubation to 25 minutes later)
- Post-extubation hypoxemia(From tracheal extubation to 25 minutes)
- Rescue analgesia requirement in the immediate postoperative time(From tracheal extubation up to first postoperative hour)
- Postoperative nausea and vomiting(From tracheal extubation to first postoperative hour)
研究者
Fredy Ariza
Anesthesiologist
Fundacion Clinica Valle del Lili