Dexmedetomidine as an Adjuvant to General Anesthesia in Patients Undergoing Elective Abdominal Hysterectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 主要终点
- Change in Serum Interleukin 6 (IL6)
研究概览
简要总结
To assess the effect of perioperative Dexmedetomidine infusion on Interleukin 6 and cortisol level in patients undergoing general anesthesia for total abdominal hysterectomy
详细描述
Following the departmental research committee approval and informed patient's consent, 52 patients, undergoing abdominal hysterectomy in Suez Canal University Hospital, will be randomly assigned to one of the two groups (Dexmedetomidine and Placebo) using a table of random numbers.
Patients will be fasting for 6 - 8 hours. All patients will receive oral Midazolam (7.5 mg), and oral Ranitidine (150mg) administered 90 min before arrival in the operating room with a sip of water.
All patients will receive before induction, normal saline 10 ml/kg body weight over 10-15 minutes. Subsequently, intravenous fluid administration will be done according to the need of each patient.
All operations will start between 08:30 am and 09:30 am, to minimize variations in cortisol level.
All patients will receive the Drug of study 10 minutes before induction of anesthesia till the start of wound closure in the form of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology physical status Grade I = (normal healthy patients)
- •American Society of Anesthesiology physical status Grade II = (patients with mild systemic disease and no functional limitations)
- •Patients scheduled for abdominal hysterectomy.
排除标准
- •Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease.
- •Known allergy to Dexmedetomidine.
- •Heart block greater than first degree.
- •Medication known to affect the sympathetic response or hormonal secretion.
研究组 & 干预措施
Dexmedetomidine
Intervention drug of the study
干预措施: Dexmedetomidine (Drug)
Placebo
Normal Saline (Placebo)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum Interleukin 6 (IL6)
时间窗: At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively
Measurement of Serum Serum Interleukin 6 in picogram / milliliter
次要结局
- Ephedrine in milligram using quessionnaire(During intraoperative time)
- Atropine in milligram using quessionnaire(During intraoperative time)
- Extubation time(Extubation)
- Visual Analogue Scale VAS of Pain intensity(VAS (visual analogue scale) at 1, 2, 4, 8, 12 and 24 hours postoperatively.)
- Change in Serum Cortisol(At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively)
- Change in Mean arterial blood pressure(Mean Arterial Blood Pressure before starting infusion of the study drug, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation)
- Change in Heart Rate (HR)(HR before starting infusion of the study drug, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation)
- Morphine Consumption in patient controlled analgesia (PCA)(Twenty four hours after attachment of patient controlled analgesia in postoperative care unit)
- Fentanyl consumption in microgram using questionnaire(During intraoperative time)
- Isoflurane in milliliter using the Ventilator reading(During intraoperative time)
研究者
Mohamed A Elsadany, MD
Principal Investigator
Suez Canal University