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临床试验/CTRI/2019/07/020225
CTRI/2019/07/020225已完成不适用

: Effect of adding dexmedetomidine to 0.75% ropivacaine in peribulbar block for vitreoretinal surgery

Narayana Nethralaya1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
The primary outcome is the requirement of supplementation of peribulbar block prior to or during the surgery.

研究概览

简要总结

Peribulbar anaesthesia is widely used in ophthalmic anaesthesia and is a suitable technique for vitreoretinal (VR) surgery. VR surgery is more painful due to the traction on the ocular muscles or sclera, increased intra-ocular pressure due to insertion of gas bubble or secondary to encirclement procedures. Good akinesia is an essential requisite for VR procedures.  Longer acting local anaesthetic agents and adjuvants have been used to prolong the duration of anaesthesia, hasten onset of akinesia, reduce LA toxicity and offer greater patient satisfaction. In this study we aim to study the efficacy of adding dexmedetomidine to 0.75% ropivacaine in PBB for VR surgery. The primary outcome is the requirement of supplementation of peribulbar block prior to or during the surgery.The secondary outcome is the pos-operative analgesic requirement. 100 adult patients undergoing VR surgery will be randomized using a computer generated random number table into one of the three groups. The composition of the study drug used for peribulbar anaesthesia in each of the 3 groups is Group R (8 ml of 0.75% Ropivacaine + 0.5 ml normal saline), Group D25 (8 ml of 0.75% Ropivacaine+ 0.25 ml Dexmedetomidine [100µg/ml] + 0.25 ml normal saline) and Group D50 (8 ml of 0.75% Ropivacaine+ 0.5 ml Dexmedetomidine[100µg/ml]). The time to onset of corneal anaesthesia and akinesia as well as the requirement for block supplementation will be recorded. The heart rate, blood pressure, saturation and sedation level will be monitored during the surgery. The duration of surgery and surgeon satiosfaction will be noted at the end of surgery.  The pain relief will be assessed at 1h, 2h, 6h and 24 h post-operatively as well as the total analgesic medication used in 24 hours. The expected outcome is superior quality block without additional supplementation and improvement in post-operative analgesia in the dexmedetomidine group.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator 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

  • 100 ASA I-III adult patients aged greater than 18 years, undergoing vitreoretinal surgery under peribulbar block will be included in the study after obtaining a written informed consent.
  • All patients will undergo routine pre-operative evaluation for vitreoretinal surgery.

排除标准

  • Patients with history of hypersensitivity to the study drugs, significant cardiovascular disease (second [Mobitz II type] or third degree heart block, obstructive sleep apnea, chronic clonidine therapy, coagulopathy, impaired mental status, refusal to use local anaesthestic technique and pregnancy will be excluded from the study.

结局指标

主要结局

The primary outcome is the requirement of supplementation of peribulbar block prior to or during the surgery.

时间窗: 0,1,2,3,4,5,10, 15 min and every 15 min till end of surgery

次要结局

  • 2. The secondary outcome is the post-operative analgesic requirement.(1h,2h,6h,24h post op)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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