Propofol-Ketamine (Ketofol) Versus Propofol-Fentanyl (Fenofol) as Procedural Sedation for Unilateral Open Carpal Tunnel Release Under Local Anesthesia
试验速览
- 阶段
- 1 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- depth of sedation
研究概览
简要总结
There are different methods of anesthesia for CTR surgery. Procedural sedation will allow rapid recovery and fewer complications than regional or general anesthesia (GA).
Attempts have been made in the past to use additives with propofol to reduce its dose. Ketofol (ketamine/propofol combination) was used for procedural sedation and analgesia. Ketamine and propofol administered in combination have offered effective sedation for spinal anesthesia and for gynecologic, ophthalmologic, and cardiovascular procedures in all age groups. The opposing hemodynamic and respiratory effects of each drug may enhance the utility of this drug combination, increasing both safety and efficacy and allowing reduction in the dose of propofol required to achieve sedation.
Propofol alone had a significantly greater number of apnea with desaturation (SpO2 < 90%) episodes. Further, it has been shown that during colonoscopies, propofol in combination with fentanyl provided similar patient satisfaction with shorter recovery times even at lower depths of sedation as compared to propofol. The addition of fentanyl to propofol has been shown to result in better operator feasibility with no difference in recovery time, cognitive impairment, or complications as compared to the use of propofol only for sedation.
详细描述
Sample size: assuming that the sedation using modified Ramasy sedation score was 6±0.01 in ketofol group versus 5.38±0.87 in fenofol group so the sample will be 56 patients, 28 patients in each group using OPENEPI at power 80 and CI 95 A computer-generated randomization table divided patients into 2 equal groups.
- Group (K) (n=28): patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
- Group (F) (n=28): patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4.
The depth of sedation will be assessed by modified Ramsay sedation
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 21-55 years old.
- •Sex: both sex (males or females).
- •Physical status: ASA I & II.
- •BMI: 25-30 kg/m
- •Type of operation: elective unilateral CTR under local anesthesia.
- •Written informed consent from the patient.
- •Cooperative patient.
排除标准
- •Patient refusal.
- •Altered mental status.
- •Patients with known history of allergy to study drugs.
- •Severe hepatic, renal, Cardiovascular and respiratory diseases.
- •Patients on regular sedative or pain killer medications.
研究组 & 干预措施
propofol-ketamine
patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4
干预措施: propofol-ketamine (Drug)
propofol-fentanyl
patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4
干预措施: propofol-fentanyl (Drug)
结局指标
主要结局
depth of sedation
时间窗: from drug injection up to 15 minutes till modified Ramsay sedation scale ≤ 4
assessed by Modified Ramsay sedation scale. Score Modified Ramsay Sedation Scale Score 1. Awake and alert, minimal or no cognitive impairment 2. Awake but tranquil, purposeful responses to verbal commands at conversational level 3. Appears asleep, purposeful responses to verbal commands at conversational level 4. Appears asleep, purposeful responses to verbal commands but at louder than usual conversational level, requiring light glabellar tap, or both 5. Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both 6. Asleep, sluggish purposeful responses only to painful Stimuli 7. Asleep, reflex withdrawal to painful stimuli only (no purposeful responses) 8. Unresponsive to external stimuli, including pain interpretation: score 1= minimal sedation score 2-4=moderate sedation score 5-7=deep sedation score 8=anesthesia
次要结局
- Total propofol consumption by mg(from the start of drug injection till discontinuation of propfol infusion about 1 hour)
- recovery time(up to 30 minutes postoperative)
- • The total duration of post-anesthesia care unit (PACU) stay (The time from arrival to the PACU to discharge to the ward) according to modified Aldrete score 9(up to 1 hour postoperative)
- number of participants with intraoperative complications such as hypotenstion, bradycardia and hypoxia(from the start of drug injection till end of surgery about 1 hour)
- number of participants with postoperative complications such as postoperative nausea and vomting(within 12 hours postoperative)
研究者
Marwa Mahmoud Abd Allah Zakzouk
principal investigator
Zagazig University