Clinical comparision of ketofol(ketamine and propofol admixture)versus propofol on quality of I-gel insertion, hemodynamic stability and recovery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- excellent / satisfactory / poor
研究概览
简要总结
Propofol is a nonopioid, nonbarbiturate, sedative-hypnotic agent with rapid induction and recovery times and antiemetic effects. propofol (diprivan , 2,6-di-isopropylphenol) is most preferred induction agent for insertion of supralaryngeal device as it allows easy insertion by depressing airway reflexes. Main disadvantage with propofol is dose-related cardio-respiratory depression and pain during bolus intravenous injection.
Ketamine causes little or no cardio-respiratory depression. Its use is limited by emergence hallucinations, elevation of blood pressure and heart rate due to its sympathomimetic effects, and increased intracranial pressure.
Effectiveness of combination of propofol and ketamine (ketofol) has been recently demonstrated and may provide a novel induction agent with favorable hemodynamics and reduced side effects attributed to either drug.
Uploaded Summary during study
Till now 45 patients in ketofol group (group KP) and 40 patients in propofol (group P) group has been evaluated.
Demographic data -
Mean age (years): group P - 29.94, Group KP - 32.5
Mean weight (kg): group P - 50.02, Group KP - 52.36
Male:female - group P - 12:33, Group KP - 23:17
Mean duration of Surgery (min): group P - 33.5, Group KP - 36.5
Mean time for loss of consciousness (secs): group P – 43, Group KP – 37
I gel insertion conditions:
Coughing/gagging:
Nil - group KP all patients, group P 35 patients, Slight - group P 05 patients
Jaw relaxation:
Excellent - group KP all patients, group P 35 patients, satisfactory – group P 05 patients
Head and neck movements:
Nil – group KP all patients, group P 38 patients, slight – group P 02 patients
Ease of insertion:
Easy – group KP all patients, group P 31 patients, difficult – group P 09 patients
Overall insertion condition:
Excellent – group KP all patients, group P 45 patients, satisfactory – 05 patients
Complications:
Pain on injection – 30 patients in group P, 05 patients in group KP
Hypotension – 15 patients in group P, 05 patients in group KP
Bradycardia – 08 patients in group P, 03 patients in group KP
Apnea – 04 patients in group P, 10 patients in group KP
Hypoventilation - 08 patients in group P, 02 patients in group
Study still continued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA grade I-IV 2.Patients who required general anesthesia.
排除标准
- •1.ASA status V 2.Hypersensitivity reaction to study drug, soyabean oil, glycerol, egg lecithin
- •Pregnant or lactating patients 4.Neonates and infants 5.Patients with history of neurologic and psychiatric diseases 6.Difficult airway.
结局指标
主要结局
excellent / satisfactory / poor
时间窗: Appropriate size I gel or LMA will be inserted after loss of consciousness and eye lid reflex. Assessments will be done only for the first attempt. duration five minutes.
Overall insertion conditions –
时间窗: Appropriate size I gel or LMA will be inserted after loss of consciousness and eye lid reflex. Assessments will be done only for the first attempt. duration five minutes.
次要结局
- observing hemodynamic parameters, recovery and complications(observation till end of surgery. duration of 60minutes.)