Comparative evaluation of perioperative outcomes of peribulbar fentanyl versus intravenous fentanyl in cataract surgeries under monitored anaesthesia care.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Analgesic efficacy of fentanyl and duration of analgesia by different routes.
研究概览
简要总结
Regional anaesthesia has gained popularity overgeneral anaesthesia owing to lesser complications, better post-operativeanalgesia and better patient compliance due to faster recovery. Cataractsurgeries are generally performed under regional anaesthesia (peribulbar block)due to short duration of surgery and ease of administration. Several drugs havebeen added as adjuvants to local anaesthetic used in peribulbar block in orderto achieve faster onset of lid and globe akinesia (to start the surgery), toprolong the duration of postoperative analgesia and to minimise the analgesicrequirement. In our study, we aim to compare the effect of adding fentanyl asadjuvant to local anaesthetic solution via two routes, i.e., peribulbar andintravenous. A total of 160 patients will be randomly divided into 2 groupswith 80 patients in each group. Group A patients will receive 25µg of fentanyldiluted up to 1ml in normal saline along with peribulbar block and group Bpatients will receive intravenous fentanyl (1µg/kg) diluted up to 10ml innormal saline prior to peribulbar block. Peri-operatively, all the patientswill be monitored for vitals such as blood pressure, pulse, respiratory rate,spo2 and ECG. Duration of analgesia, time for rescue analgesic and number ofanalgesic doses needed to relieve the pain will be recorded in both groupspostoperatively upto 24 hours. Thereafter, comparisons will be made among the twogroups based on the data collected. The different variables and occurrence ofside effects, if any, would also be noted and compared amongst both groups. Theanticipated outcome of the study will be in terms of duration of analgesia bydifferent routes and patient and surgeon satisfaction satisfaction scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American society of anaesthesiologists (ASA) grade I to III patients.
- •2.Patients in the age group of 40-80 years will be included in the study.
- •3.Patients of all genders.
- •4.Patients who are willing to provide their voluntary written informed consent for participation in the study.
排除标准
- •1.Patients who are not willing to give their consent for participation in the present study.
- •2.History of allergy to the drug under study or local anaesthetics used.
- •3.Patients who have known coagulation abnormalities, patients with impaired orbital and periorbital sensation, disturbed conscious level, active respiratory disease, poor communication ability as deafness and patients with excessive tremors or agitations.
- •4.Patients with abnormal ocular conditions as vitreous haemorrhage, posterior staphyloma and glaucoma.
- •5.Patients previously on treatment with chronic analgesics and antipsychotic drugs.
结局指标
主要结局
Analgesic efficacy of fentanyl and duration of analgesia by different routes.
时间窗: From the time of administration of fentanyl to maximum of 24 hours postoperatively.
次要结局
- Side effects and patient and surgeon satisfaction scores.(From the time of administration of fentanyl to maximum of 24 hours postoperatively.)