Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patient Satisfaction with Sedation Instrument (PSSI)
研究概览
简要总结
This randomized controlled pilot clinical trial will enroll patients undergoing dynamic flexible bronchoscopy will be randomized to receive one of the two anesthetic combinations described above. The study will determine if there is a difference when considering patient and physician and satisfaction when performing DFB. Also, safety and efficacy of the two pharmacological combinations (fentanyl + midazolam and remifentanil + ketamine) used will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Remifentanil and Ketamine Group
Patients in Group 1 will receive remifentanil and ketamine. Remifentanil will be administered initially with a 1mcg/kg IV bolus followed by a continuous infusion, 0.1 to 0.15 mcg/kg/min IV (using ideal body weight) with titration to a maximum dose of 0.2 to 0.4 mcg/kg/min IV. Total dose of ketamine will be titrated from 10 to 40 mg, based on clinical judgment, and it will be recorded. Ketamine will be delivered using 2mL syringes, previously filled with ketamine in normal saline at a 10mg/mL concentration.
干预措施: Remifentanil (Drug)
Remifentanil and Ketamine Group
Patients in Group 1 will receive remifentanil and ketamine. Remifentanil will be administered initially with a 1mcg/kg IV bolus followed by a continuous infusion, 0.1 to 0.15 mcg/kg/min IV (using ideal body weight) with titration to a maximum dose of 0.2 to 0.4 mcg/kg/min IV. Total dose of ketamine will be titrated from 10 to 40 mg, based on clinical judgment, and it will be recorded. Ketamine will be delivered using 2mL syringes, previously filled with ketamine in normal saline at a 10mg/mL concentration.
干预措施: Ketamine (Drug)
Fentanyl and Midazolam
The patients in this group will receive fentanyl doses that range between 0.5 to 2 mcg/kg (25 - 50 mcg) IV bolus in combination with midazolam 1-5 mg bolus over at least 2 minutes as determined by attending anesthesiologist (not to exceed 2.5 mg / 2 min per package insert). Total dosing of fentanyl and midazolam may be titrated, based on clinical judgment, and it will be recorded. Maintenance, additional midazolam doses of 25% of total initial dose required to achieved desired sedation may be administered IV if additional sedation is considered necessary
干预措施: Fentanyl (Drug)
Fentanyl and Midazolam
The patients in this group will receive fentanyl doses that range between 0.5 to 2 mcg/kg (25 - 50 mcg) IV bolus in combination with midazolam 1-5 mg bolus over at least 2 minutes as determined by attending anesthesiologist (not to exceed 2.5 mg / 2 min per package insert). Total dosing of fentanyl and midazolam may be titrated, based on clinical judgment, and it will be recorded. Maintenance, additional midazolam doses of 25% of total initial dose required to achieved desired sedation may be administered IV if additional sedation is considered necessary
干预措施: Midazolam (Drug)
结局指标
主要结局
Patient Satisfaction with Sedation Instrument (PSSI)
时间窗: Two hours after procedure conclusion, prior to patient discharge from the hospital
The primary outcome will be a difference in patient satisfaction with sedation, as determined by a 5-point difference in the PSSI questionnaire. The total score will be assessed by summing the responses to each question. In the scale, 0 will denote no satisfaction (worst outcome) and 100 will represent the greatest possible satisfaction (best outcome).
次要结局
- Numerical Rating Scale (NRS) for Discomfort(Two hours after procedure conclusion, prior to patient discharge from the hospital)
- Duration of Dynamic Flexible Bronchoscopy(Two hours after procedure conclusion, prior to patient discharge from the hospital)
- ALDRETE score(Two hours after procedure conclusion, prior to patient discharge from the hospital)
- Clinician Satisfaction with Sedation Instrument (CSSI)(Two hours after procedure conclusion, prior to patient discharge from the hospital)
- Severity of Cough(Two hours after procedure conclusion, prior to patient discharge from the hospital)
- Total Nebulized Lidocaine Dose(Until discharge from the PACU, on average one hour)
- Incidence of Complications(Two hours after procedure conclusion, prior to patient discharge from the hospital)
- PACU Length of Stay(Until discharge from the PACU, on average one hour)
研究者
Satya Krishna Ramachandran
Vice Chair of Quality and Safety, Associate Professor of Anaesthesia
Beth Israel Deaconess Medical Center