Comparison Between Dexmedetomidine and Lidocaine as an Adjuvant to General Anesthesia in Patients Undergoing Major Abdominal Surgeries
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 主要终点
- Change in Serum Interleukin 6 (IL6)
研究概览
简要总结
assessing the effect of perioperative infusion of Dexmedetomidine versus Lidocaine on neuro endocrine stress response to surgery and anesthesia
详细描述
Methodolgy
During the preoperative visit, the techniques will be explained to patients including benefits and complications.
- Pre-operative assessment:
A) Medical history:
- Medical disorders as hypertension, diabetes, heart, chest, liver or kidney diseases.
- Past history of operations, hospitalization or blood transfusion.
- Past anesthetic history with impact on previous airway problems during previous surgeries, hypersensitivity to anesthetic medications, any previous post-operative complications that could be attributed to anesthesia.
- Family history for specific anesthetic problems like malignant hyperthermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender.
- •Consent from patients about technique and nature of the study.
- •Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II).
- •Patients scheduled for major abdominal surgery.
排除标准
- •Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease
- •Known allergy to Dexmedetomidine or Lidocaine.
- •History of endocrine disorders.
- •Heart block greater than first degree.
- •Medication known to affect the sympathetic response or hormonal secretion.
研究组 & 干预措施
Dexemetomidine
Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure.
干预措施: Dexmedetomidine (Drug)
Lidocaine
Lidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Change in Serum Interleukin 6 (IL6)
时间窗: Serum Interleukin 6 will be measured at baseline and then 2 hours after induction of surgery and then 6 hours postoperative
Serum Interleukin 6 will be measured in picogram/Milliliter
次要结局
- Ephedrine(During intraoperative period)
- Morphine consumption(Morphine consumption during first 24 hours postoperatively)
- Changes in Heart Rate (HR)(Baseline HR, 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 Serum Cortisol(Serum Cortisol will be measured as baseline and then 2 hours after induction of surgery and then 6 hours postoperative)
- Changes in Mean Arterial Blood Pressure (MABP)(Baseline MABP, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation)
- Atropine consumption using questionnaire(During intraoperative period)
- Visual analogue scale VAS(VAS (visual analogue scale) at 1, 2, 4, 8, 12 and 24 hours postoperatively.)
研究者
Mohamed A Elsadany, MD
Principal Investigator
Suez Canal University