The Recovery Profile of Different Doses of Remifentanil After Desflurane Inhalational Anesthesia for Bariatric Surgeries: Two Centers Controlled Prospective Study
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 主要终点
- Changes in hemodynamic
研究概览
简要总结
The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Difficult airway increases by 30% with obesity and so awake extubation are the preferred technique. Coughing can be alleviated by opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an ultra-short acting opioid and its effect swiftly and predictably disappears after cessation. An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI), and the expected effective effect-site concentrations investigated have ranged from 1.5 to 2.5 ng.ml/L.
详细描述
The investigators designed this study to examine the effect of different small doses of Remifentanil on the incidence of cough reflex during emergence from anesthesia in obese patients undergoing bariatric surgery. The investigators will study if these small doses will delay the recovery of the patient or not. The other expected side effects will be observed eg. Respiratory depression. Time to the first painkiller required will be registered
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)
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
- •Age≥ 18 years
- •Subject has signed informed consent for bariatric laparoscopic surgery.
- •Subject must be ASA I or ASA II according to the American Society of Anesthetists classification.
排除标准
- •Age < 18 years.
- •Smoking patient.
- •Hypertension.
- •Bronchial asthma.
- •Obstructive sleep apnea syndrome.
研究组 & 干预措施
Group 1(Normal saline)
Patients who will receive placebo (one ml normal saline). The drug will be given after closure of desflurane at an exhaled MAC of 0.3.
干预措施: Normal Saline (Drug)
Group 2 (Remifentanil 0.1 ug/kg)
Patients who will receive remifentanil at a dose of 0.1 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3.
干预措施: Remifentanil 0.1 ug/kg (Drug)
Group 3 ((Remifentanil 0.2 ug/kg))
Patients who will receive remifentanil at a dose of 0.2 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3.
干预措施: Remifentanil 0.2 ug/kg (Drug)
结局指标
主要结局
Changes in hemodynamic
时间窗: within the first 24 hours
Mean blood pressure and heart rate will be recorded before surgery and combined with all the other study items at the end of surgery, at the extubation time, after 5 minutes in PACU, after 10 minutes in Postanesthesia Care Unit (PACU) and he last registered reading in PACU.
antitussive effect
时间窗: within the first 24 hours
cough assessment at recovery time 0 no cough 1. single cough 2. cough episode less than five seconds or multiple coughs 3. sustained attack of cough lasts more than five seconds
次要结局
- Respiratory depression(within the first 24 hours)
- Postoperative pain(within the first 24 hours)
研究者
Dr Mohamed Shaaban Ali, PhD, MD
Associate Profossor of Anesthesiology
Assiut University