The Effect of Ketamine - Dexmedetomidine Admixture (Ketodex) on Hemodynamic Stability During Anesthesia Induction in Adults: A Randomized Controlled Comparison of Two Doses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of post-induction hypotension
研究概览
简要总结
The aim of our study to compare two different doses of Dexmedetomidine added to anesthetic dose of ketamine in the induction of general anesthesia in adult patients regarding the hemodynamic profile, adequacy of hypnosis, intubation conditions and recovery type.
We hypothesize that the use of Ketodex during induction of general anesthesia will produce better control regarding the hemodynamic profiles and quality of intubation than propofol.
详细描述
A randomized, double-blinded, controlled trial. All adult patients (ASA I and II), aged > 18 years old undergoing elective general surgery and meeting the inclusion criteria will be included in the study.
The patients will be divided into 3 equal groups: Propofol group (p), Ketamine-Dexmedetomidine (KD5) group and Ketamine-Dexmedetomidine (KD3) group.
In the operating room; Baseline preoperative arterial pressures (systolic, mean& diastolic) will be the mean of 3 consecutive readings with 30 seconds apart, recorded in the supine position. HR and oxygen saturation baseline will also be recorded.
drug preparation: Propofol (P) group: Propofol(2mg/kg) prepared as will be mixed with 2 mL Lidocaine (40 mg) for concentration 10mg/ml and fentanyl (1mic/kg) prepared for concentration 10mg/ml in 2 separate syringes.
Ketamine-Dexmedetomidine (KD5) group: ketamine (1mg/kg) prepared for concentration 10mg/ml, Dexmedetomidine (0.5microg/kg slow IV) prepared for concentration of 5mic /ml in 2 separate syringes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •All patients undergoing elective general surgery. Patients aged >18 years. ASA I and II. Both sexes.
排除标准
- •All patients undergoing emergency surgery. Patients less than 18 years. History of difficult intubation, abnormal airway examination Cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias, tight valvular lesions).
- •Patients on angiotensin converting enzyme inhibitors and angiotensin receptor blockers medications.
- •Patients with uncontrolled hypertension. Patients with allergy of any of the study drugs. Body mass index > 35 kg/m2
研究组 & 干预措施
Ketamine-Dexmedetomidine (KD3) group
ketamine (1mg/kg) prepared concentration 10mg/ml, Dexmedetomidine (0.3microg/kg slow IV) prepared for concentration of 3mic /ml in 2 separate syringes.
干预措施: ketamine- dexmeditomidine admixure (Drug)
Propofol (P) group
Propofol(2mg/kg) prepared as will be mixed with 2 mL Lidocaine (40 mg) for concentration 10mg/ml and fentanyl (1mic/kg) prepared for concentration 10mg/ml in 2 separate syringes.
干预措施: Propofol, Lidocaine and fentanyl (Drug)
Ketamine-Dexmedetomidine (KD5) group
ketamine (1mg/kg) prepared for concentration 10mg/ml, Dexmedetomidine (0.5microg/kg slow IV) prepared for concentration of 5mic /ml in 2 separate syringes.
干预措施: ketamine- dexmeditomidine admixure (Drug)
结局指标
主要结局
Incidence of post-induction hypotension
时间窗: the first 20 min after general anaesthesia induction.
mean arterial pressure MAP \< 65 mmHg and/or≤ 70% of baseline reading for \> 10 s
次要结局
- Total Ephedrine requirements(during the period from induction anesthesia to skin incision. maximum 30 minutes)
- Response to intubation score.(maximum 5 minutes)
- Total dexmedetomidine, ketamine and propofol dose per weight.(the whole procedure . 2 hours)
- Incidence of emergence agitation using Riker Sedation-Agitation Scale(60 minutes)
- Severe post-induction hypotension (mean arterial pressure ≤60 mmHg), hypertension, bradycardia, and tachycardia(during 30 min from induction anesthesia.)
- Intubation time (time from insertion of the laryngoscope into the mouth until its removal after tracheal intubation)(maximum 5 minutes)
- Total Atropine requirements(during the period from induction anesthesia to skin incision. max 30 minutes)
- The Number of hypotensive episodes(the 2 hours procedure)
- Recovery time(less than 15 minutes)
研究者
Amany Ahmed Eissa
lecturer of anesthesia& ICU
Kasr El Aini Hospital