The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
研究概览
简要总结
The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy
详细描述
Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural sedation.
The investigator compared the effect of propofol and propofol ketamine in patients undergoing drug induced sleep endoscopy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old.
- •American society of anesthesiologists (ASA) physical status I or II. I / II
排除标准
- •patient refusal
- •American society of anesthesiologists (ASA) physical status > III
- •known or suspected allergy to the studied drugs or its components, allergy to eggs or soy beans
- •morbid obesity
- •patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled asthma, congestive e heart failure ,seizures ,or cerebrovascular disease
- •pregnancy
研究组 & 干预措施
propofol ketamine (pk)
patients will receive ketamine in addition to propofol intravenous for sedation
干预措施: Ketamine + propofol (Drug)
propofol (P)
patients will receive only propofol intravenous for sedation
干预措施: propofol (Drug)
结局指标
主要结局
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
时间窗: the duration of the procedure under sedation is usually about 20 minutes to complete the procedure
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
次要结局
- any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction(the procedure)
- time until sufficient sedation to start endoscopy(It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy)
- The total propofol and ketamine dose(mg)/patient needed/patient was calculated(the procedure)
- Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure(the procedure)
- Time till Recovery(an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4)
- patients and surgeon satisfaction(about 30 minutes after complete recovery both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied)
- Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room(Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room)
研究者
Heba Mohamed EL -Asser,MD
principal investigator
Zagazig University