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临床试验/CTRI/2020/01/022922
CTRI/2020/01/022922尚未招募不适用

To compare the effectiveness of dexmedetomidine versus combination of lignocaine and dexamethasone on postoperative sore throat in patients undergoing elective laparoscopic surgery in Trendelenburg position

Dr Divya Abhishek Kishore1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年1月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
135
试验地点
1
主要终点
Post operative sore throat

研究概览

简要总结

This is a prospective , double blind, single centric, three arm, randomized controlled trial comparing two groups of anaesthetic drugs with eachother and with placebo for prevention of post operative sore throat in 135 adult patients of either sex undergoing elective laparoscopic surgery in Trendelenburg position. The patients shall be randomly allocated to either of the three groups D (1microgram/kg dexmedetomedine),group LS(ligocaine 1.5mg/kg+8mg dexamethasone),group N(normal saline). These drugs are expected to reduce the incidence and severity of post operative sore throat both at rest and during swallowing. The primary outcome measure is postoperative sore throat at 15mins, 1h, 6h,12h and 24h postoperatively. The secondary outcome measures are postoperative sore throat on swallowing at 15min, 1h, 6h, 12h and 24 h post operatively, total morphine consumption measured at 24h postoperatively, percentage of glottic opening score measured at 2sec before intubation and blood staining of  the endotracheal tube noted 30sec post extubation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I-III, Undergoing elective laparoscopic surgery in Trendelenburg position Requiring endotracheal intubation Duration of surgery>90minutes Expected to remain admitted in the hospital for >24hours.

排除标准

  • Patients with preexisting sore throat/ hoarsen · ASA physical status IV · BMI > 30 · Vocal performer by occupation · Recent or recurrent respiratory tract infection ·Risk of postoperative aspiration (obesity, pregnancy ) · Pain medications, corticosteroids ; calcium channel blocker · 2nd and 3rd degree Heart block · Allergy to Study drugs ·Anticipated difficult intubation(Mallampati grade >2, difficult mask ventilation requiring oral/nasal airway, Cormack and Lehane grade III-IV) Intubation attempt >1.

结局指标

主要结局

Post operative sore throat

时间窗: 15min,1h,6h,12h,24h

次要结局

  • Post operative sore throat on swallowing(15min,1h,6h,12h,24h)
  • Percentage of glottic opening score(2 seconds before endotracheal intubation)
  • Bloodstain over endotracheal tube(30 sec post extubation)
  • Total morphine consumption(24h after surgery)

研究者

发起方
Dr Divya Abhishek Kishore
申办方类型
Other [self]

研究点 (1)

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