Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients with Two Doses of Remifentanil: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- percentage of patients with excellent conditions of intubation
研究概览
简要总结
This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents.
During the induction of general anesthesia, Propofol - Remifentanil combination will be used.
The patients will be randomized in 2 groups with different doses of Remifentanil.
详细描述
The prevalence of obesity increases steadily. For anesthesiologists, the airway management of obese patients is known to be difficult and at risk. Tracheal intubation needs to be successful quickly. Neuromuscular blocking agents allow this option but with a risk of anaphylaxis and respiratory complications. In fact, for many surgical procedures those drugs are not necessary.
Numerous studies in non-obese patients with the combination of Remifentanil and Propofol have shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. This combination has never been studied in obese patient.
After randomization, induction of general anesthesia will be performed with 2,5 mg/kg of Propofol in association with either 3 µg/kg of Ideal Body Weight of Remifentanil, or 3 µg/kg + 30% of Ideal Body Weight of Remifentanil.
Minutes after the induction, orotracheal intubation will be performed, and the Intubation Difficulty Scale recorded.
Other data on hemodynamic, respiratory and airway management will be are collected during the surgery.
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, Investigator, Outcomes Assessor)
盲法说明
with randomization envelopes opened by the care provider
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 and under 60 years old.
- •ASA score ≤ 3
- •Elective bariatric surgery for patient with BMI between 35 and 60 or elective revision of a bariatric surgery for patient with a BMI over
- •Patient with a written consent obtained with accurate information.
排除标准
- •Patient with risk of aspiration
- •Difficult airway known (Cormack score 3 ou 4).
- •Opioids addiction.
- •Alcoholism
- •Chronic use of Opioids
- •Confirmed Allergy to Propofol or Remifentanil
- •Severe chronic hepatic, kidney or respiratory failure
- •Patient already enrolled in another clinical study interfering with this study.
研究组 & 干预措施
Group control
3 μg/kg (Ideal Body Weight) of Remifentanil
干预措施: Remifentanil Injection (Drug)
Group Active
3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil
干预措施: Remifentanil Injection plus 30% (Drug)
结局指标
主要结局
percentage of patients with excellent conditions of intubation
时间窗: Baseline
Intubation conditions will be assessed using the intubation conditions score proposed by Viby-Mogensen and al. (Scandinavian score). The score defines intubation conditions: excellent (all variables are excellent), good (all variables are either excellent or good), or poor (presence of a poor variable).
次要结局
- Hemodynamic effects : hypotension(Baseline)
- Hemodynamic effects: bradycardia(Baseline)
- Hemodynamic effects: use of vasopressor drugs(Baseline)
- Respiratory effects: patients with desaturation day 0(Baseline)
- Respiratory effects: patients with aspiration(From Baseline to day 2)
- Intubation complexity(Baseline)
- Intubation difficulties with Cormack-Lehane classification(Baseline)
- Percentage of use of the study's emergency(Baseline)
- Traumatic complications: anatomical lesion(Baseline)
- Traumatic complications: postoperative functional discomfort(Day 2)