Comparison of Intravenous Lidocaine and dexmedetomidine Infusions on quality of recovery (QoR-15) and quality of surgical field in functional endoscopic sinus surgery (FESS): A Randomized, Double-Blinded, Controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine, dexmedetomidine infusion and placebo infusion
研究概览
简要总结
This proposed study will be a single institution, double-blinded, prospective randomized placebo-controlled trial conducted on 96 patients aged 18 - 60 years old, of either sex, American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for elective functional endoscopic sinus surgery under general anaesthesia.
Patients will be randomly divided in to 3 groups.
*Group1(L):*Loading dose of IV lidocaine 1.5 mg/kg slowly just before induction of anesthesia, then the lidocaine infusion started at a rate of 1.5 mg/kg/h.
*Group 3 (D):):*Loading dose of IV Dexmedetomidine 1 µg/kg slowly just before induction of anesthesia, then the dexmedetomidine infusion started at a rate of 0.5 µg/kg/h.
Group 2(Placebo): Equal volume of 0.9% sodium chloride as the Lidocaine group (both the loading, and the infusion)
Patients will be evaluated forMean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine infusion and placebo infusion (Primary outcome) and Mean /median quality of surgical field score (for the severity of bleeding and the need for frequent suctioning) among study groups, Mean total analgesic consumption in the first 24 postoperative hours (Intra-operative + post- operative analgesic consumption) among study groups, Mean changes in hemodynamic parameters such as Heart rate (HR) and Blood pressure (Systolic, Diastolic, Mean) among study groups and Percentage of patients experiencing adverse events or complications if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged
- •60 years old, of either sex, American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for elective functional endoscopic sinus surgery under general anaesthesia.
排除标准
- •Patient’s refusal, Allergies to local anesthetic drugs Significant cardiovascular disease, hepatic dysfunction or renal dysfunction, Known coagulation defects, Inability to communicate, Chronic opioid usage, Poorly controlled hypertension, Use of B- Blockers, History of Bradycardia episodes /Atrio-ventricular block / Conduction defects.
结局指标
主要结局
Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine, dexmedetomidine infusion and placebo infusion
时间窗: Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine, dexmedetomidine infusion and placebo infusion
次要结局
- Mean /median quality of surgical field score (for the severity of bleeding and the need for frequent suctioning) among study groups(Mean total analgesic consumption in the first 24 postoperative hours (Intra-operative + post- operative analgesic consumption) among study groups)
研究者
Dr Priyanka Dwivedi
AIIMS GKP