A comparative study on the effect of Dexmedetomidine versus Magnesium sulphate on postoperative delirium in the patients undergoing head and neck oncological surgeries- A prospective randomized study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess postoperative delirium using CAM-ICU score in patients undergoing head and neck surgeries in dexmedetomidine and magnesium sulphate group
研究概览
简要总结
Postoperative delirium is acute fluctuating course in attention with disturbance in attention and cognition which leads to increase in hospital stay and increased morbidity is crippling complication of the head and neck oncological surgery. To ameliorate this complications both pharmacological and non-pharmacological measures have been used. Drugs like dexmedetomidine, ketamine, dexamethasone, magnesium sulphate have been proposed to decrease the occurrence of delirium and emergence agitation. Informed consent will be taken by the principal investigator from all the patients fulfilling inclusion criteria by explaining the details of the study in their own language in presence of a witness. A computer generated randomization of the selected patients according to the inclusion criteria and group will be assigned. Preoperatively, Mental status will be assessed using Mini Cog a day prior to the surgery. Preoperative orders will be given as per institutional protocol and patients will be advised to skip the benzodiazepines a night before the surgery. On the day of surgery patient will be shifted to operation theatre and after noting the baseline haemodynamic parameters, patient will be intubated as required for the head and neck surgery. After the induction the patient will be given the drug as the allocated group.
Group D – Dexmedetomidine infusion-0.5 mcg/kg loading dose over 10 minutes followed by 0.5 mcg/kg/hour intravenously
Group M – Magnesium sulphate infusion- 30 mg/kg loading dose over 10 minutes followed by10 mg/kg/hour intravenously
Intraoperatively haemodynamic parameters will be noted after the loading dose of infusion and thereafter every hourly. Rescue fentanyl (1 mcg/kg) will be administered if heart rate and blood pressure increased to more than 20%. Analgesia will be maintained with paracetamol 1gm and additional dose of opioids or analgesics as required.
Patient will be shifted to ICU for postoperative mechanical ventilation and patient will be sedated with intravenous fentanyl. Patient will be extubated on postoperative day 1 after fulfulling the extubation crtieria. CAM-ICU score and sleep quality will be assesed using Richard campbell Questionnaire on postoperative day 2 and 5. Patient will be discharged as the surgical team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I and II Planned for head and neck oncological surgery.
排除标准
- •Patient with psychological disorder Patient with history of stroke or cognitive dysfunction Patient with inability to communicate (coma, language barrier, deaf ) Chronic or acute intake of sedative or anticonvulsant drug Patients with severe cardiac dysfunction, renal or hepatic dysfunction Bradycardia (Heart rate less than 50 bpm) Allergy to study drugs Surgical duration more than 6 hours.
结局指标
主要结局
To assess postoperative delirium using CAM-ICU score in patients undergoing head and neck surgeries in dexmedetomidine and magnesium sulphate group
时间窗: Postoperative day 2(T1) | Postoperative day 5 (T5)
次要结局
- To monitor effects of dexmedetomidine and magnesium sulphate on heart rate and BP Introperatively(Baseline(T0))
- To record total dose of intraoperative fentanyl used to evaluate opioid -sparing effect of each agent(At the end of surgery)
- To assess the sleep quality using Richard Campbell Sleep Questionnaire(Postoperative day 2)
研究者
Dr Bhagyashree
AIIMS, Bhopal