A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total Midazolam
研究概览
简要总结
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
详细描述
All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP
排除标准
- •History of inability to complete bronchoscopy attributable to inadequate sedation
- •Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%
- •History of allergy to study medications
- •Pregnancy
- •A history of psychosis
- •Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease
- •Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist
- •A diagnosis of significant renal or hepatic impairment
研究组 & 干预措施
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
干预措施: Midazolam load (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
干预措施: Fentanyl load (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
干预措施: Midazolam demand (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
干预措施: Fentanyl demand (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
干预措施: Benadryl demand (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
干预措施: Dexmedetomidine load (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
干预措施: Ketamine load (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
干预措施: Dexmedetomidine maintenance (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
干预措施: Ketamine maintenance (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
干预措施: Midazolam demand (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
干预措施: Fentanyl demand (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
干预措施: Benadryl demand (Drug)
结局指标
主要结局
Total Midazolam
时间窗: Duration of procedure
Total midazolam delivered during procedure
Decreased Minute Ventilation
时间窗: During the bronchoscopy procedure only, 58.5 minutes average
An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.
Total Fentanyl
时间窗: During the bronchoscopy procedure only, 58.5 minutes average
Total fentanyl dose delivered during the procedure
次要结局
- Desaturation (Cumulative)(During the bronchoscopy procedure only, 58.5 minutes average)
- Conversion to General Anesthesia(During the bronchoscopy procedure only, 58.5 minutes average)
- Patient Satisfaction(After the bronchoscopy procedure only)
- Endoscopist Satisfaction(After the bronchoscopy procedure only)
- Desaturation (Longest)(During the bronchoscopy procedure only, 58.5 minutes average)