Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam for Patient Sedation During Flexible Bronchoscopy: a Prospective, Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Depth of sedation Ramsay
研究概览
简要总结
Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. This study aimed to compare the standard recommended combination of midazolam-fentanyl (MF) with that of dexmedetomidine-ketamine (DK) for patient sedation during FB. Patients subjected to FB were randomly assigned to a DK (n=25) and an MF group (n=25). The primary outcome was the rate of critical desaturation events (arterial oxygen saturation <80% with nasal oxygen supply 2 L/min). Secondary outcomes included sedation depth, hemodynamic complications, adverse events, and patient and bronchoscopist satisfaction.
详细描述
Study design and population This randomized controlled trial of adult patients (age >18 years) scheduled for FB was conducted between September 2019 and May 2020 at the Respiratory Medicine Department of Athens Naval Hospital, Greece.
Exclusion criteria included: known or suspected allergy to any of the study drugs, renal impairment (serum creatinine > 2 mg/dL), hepatic impairment (liver enzymes > 2 times the upper limit of normal), seizure disorders, history of psychosis or bipolar disorder, hemodynamic instability (heart rate - HR < 50 bpm or systolic blood pressure - SBP < 90 mmHg), and critically ill patients. The study protocol was approved by the Ethics Committee of Athens Naval Hospital (act number 296/13.08.2019), and written informed consent was obtained from all participants.
Protocol Demographic data and medical history were reviewed at the presentation, and the vital signs were assessed and recorded.
Eligible patients were then randomly assigned to two groups:
- DK group: Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given. An increase of 0.1 μg/kg in the infusion rate of dexmedetomidine was considered when necessary to optimize the level of sedation.
- MF group: Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for flexible bronchoscopy at the Naval Hospital of Athens
- •Written informed consent
排除标准
- •known or suspected allergy to any of the study drugs
- •renal impairment (serum creatinine > 2 mg/dL)
- •hepatic impairment (liver enzymes > 2 times the upper limit of normal)
- •seizure disorders
- •history of psychosis or bipolar disorder
- •hemodynamic instability (heart rate - HR < 50 bpm or systolic blood pressure - SBP < 90 mmHg)
- •critically ill patients.
研究组 & 干预措施
DK group
Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given.
干预措施: Dexmedetomidine (Drug)
DK group
Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given.
干预措施: Ketamine (Drug)
MF group
Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered.
干预措施: Midazolam (Drug)
MF group
Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Depth of sedation Ramsay
时间窗: Minute 90 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Bronchoscopist satisfaction
时间窗: 1 hour after the end of the procedure
Bronchoscopist satisfaction was measured with a Likert-scale tool answering the question "How satisfied are you with both the ease and outcome of the procedure?" as follows: 1 = not satisfied at all; 2 = somewhat satisfied; 3 = more satisfied with the procedural outcome; 4 = mostly satisfied with the outcome and somewhat with procedural ease; 5 = exceptionally satisfied with both procedural outcome and ease.
Depth of sedation Riker
时间窗: Minute 90 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of \<4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Patient satisfaction
时间窗: 24 hours after bronchoscopy
Patient satisfaction was evaluated by a short, custom-made questionnaire that included the following questions: 1) I was satisfied with the sedation administered for the procedure, 2) I felt pain and/or discomfort beyond my tolerance during the procedure, 3) I believe my needs were met during the procedure 4) I felt pain and discomfort after the procedure, 5) I would be willing to undergo a second procedure if the first did not yield adequate results. The responses were measured in a Likert scale format with values 1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 =strongly agree. Questions 2 and 4 were scored reversely.
次要结局
未报告次要终点
研究者
Fouzas Sotirios
Assoc. Professor of Pediatric Respiratory Medicine
University of Patras