Comparison of the efficacy of Dexmedetomidine versus Ketamine as an adjunct to Ropivacaine for Scalp Block during Awake Craniotomy Surgery- A Clinical Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ankur Luthra
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Time to first request of rescue analgesic drug by the patient in the postoperative period which is defined as the time interval between onset of sensory blockade to the first use of rescue analgesic drug as demanded by the patient (NRS more than 4)
研究概览
简要总结
In summary, Dexmedetomidine and Ketamine can be effective adjuvants for Scalp Block Anaesthesia, with different profiles of efficacy and side effects. The choice of adjuvant should be based on the specific needs of the patient and the procedure, as well as the cliniciann’~~’~~s experience and comfort with each drug.Since there is no study comparing the effectiveness of Dexmedetomidine versus Ketamine as an adjuvant for Scalp Block in adults, we would like to compare the effectiveness of Dexmedetomidine (1 μg/kg) with Ketamine (0.5 mg/kg) as an adjuvant to 20 ml 0.5% Ropivacaine for Scalp Block infiltration in adult population aged 18-65 years undergoing Awake Craniotomy surgery. We hypothesize that addition of Ketamine 0.5 mg/kg is comparable to Dexmedetomidine 1 μg/kg as adjuncts to Ropivacaine 0.5% for prolonging the duration of analgesia post-Scalp Block in patients undergoing Awake Craniotomy surgery.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •46 ASA I and II patients aged between 18-65 years scheduled for Elective Awake Craniotomy surgery for brain tumors will be enrolled in this study.
排除标准
- •Refusal of consent ii.
- •Known allergy to Dexmedetomidine or Ketamine iii.
- •Prior Craniotomy / Chronic analgesic use iv.
- •Coagulopathy v.
- •Schizophrenia or bipolar disorders vi.
- •Uncontrolled anxiety or depression vii.
- •BMI >35 kg/m2 ix.
- •Significant Respiratory disease (COPD or Asthma requiring daily therapy) x.
- •Significant Cardiovascular disease (2nd/3rd degree heart block, Congestive heart failure, symptomatic coronary artery disease).
结局指标
主要结局
Time to first request of rescue analgesic drug by the patient in the postoperative period which is defined as the time interval between onset of sensory blockade to the first use of rescue analgesic drug as demanded by the patient (NRS more than 4)
时间窗: Within 24 hours whenever NRS more than 4
次要结局
- To compare the time needed for onset of sensory block assessed by loss of pin prick sensation every 1 minute.
- To assess the intraoperative hemodynamics (HR, NIBP, MAP, RR, SpO2) at 10 min interval and postoperatively at 2 hours interval till 24 hours.
- 3. To assess the sedation score intraoperatively by Richmond Agitation And Sedation Scale39 (RASS) at 10 min interval after opening of dura for allowing neurological testing (power, speech, calculation, language etc.(10 min and after opening of dura)
- 4. To assess the Pain scores by Numerical Rating Scale (NRS) postoperatively at 2 hourly intervals till 24 hours.(2 hourly till 24 hours)
- To assess the number of episodes of of adverse events like bradycardia, hypotension, respiratory depression, psychosis by SOMC scale and PONV by 4-Point PONV scale(Till 24 hours)
- Total rescue analgesic drug requirement in 24 hours.(24 hours)
- Time to discharge from PACU using Modified Aldrete Scoring(Time to discharge)
研究者
Ankur Luthra
Post Graduate Institute of Medical Education and Research, Chandigarh