Dexmedetomidine Versus Ketorolac/ Midazolam on Perioperative Outcome During Retinal Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Changes in blood pressure
研究概览
简要总结
To evaluate and compare the effect of administration of intravenous ketorolac- midazolam or dexmedetomidine as adjuvants to general anesthesia on perioperative outcome during retinal surgery.
详细描述
regarding patient registry; G power analysis was done was done to estimate the sample size. Assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 18 patients per group would be sufficient to detect a difference 20 % in hemodynamics indices among the groups. A drop out 10% of cases was expected therefore 20 patients were required in each group to detect the difference.
- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Kolmogorov-Smirnov test. Data is presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, one way ANOVA test will be used to compare between mean values of three groups with post hoc Bonferroni test for paired comparisons. Repeated measures ANOVA with post hock Bonferroni will be used for intra-groupal comparisons. For non-parametric data, Kruskal Wallis H test to compare between median values of 3 groups with Mann Whitney U test for paired comparisons. Chi Square test will be used for testing significance of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status |or ||
排除标准
- •Mental disorders.
- •Psychological disorders.
- •Neurological disorders.
- •Hyper reactive airway disease.
- •History of sleep apnoea.
- •Severe cardiovascular disease.
- •Respiratory disease.
- •Hepatic disease.
- •Renal impairment.
- •Known sensitivity to any of study drugs.
- •History of alcohol.
- •History of drug abuse.
- •Morbid obesity (body mass index >35).
- •Pregnancy.
- •Lactating women.
- •Patient refusal.
研究组 & 干预措施
Dexmedetomidine group (D)
Patients received 1ug/kg dexmedetomidine in 50 ml saline over 10 min i.v 30 min before induction then 0.4 ug/kg/h dexmedetomidine (4ug/ml) and normal saline 0.1 ml/kg till end of surgery, using two syringe pumps one for dexmedetomidine and the other for saline
干预措施: Dexmedetomidine group (D) (Drug)
Ketorolac-Midazolam group (KM)
Patients received 0.5mg/kg ketolac in 50 ml saline over 10 min before induction and 25ug/kg midazolam in 50 ml saline over 10 min i.v 30 min before induction then 50ug/kg/h of ketolac and 40ug/kg/h midazolam till end of surgery in two separate syringe pumps.
干预措施: Ketorolac-Midazolam group (KM) (Drug)
Control group (Normal Saline) (C)
Patients received same volume of normal slaine in two sets.
干预措施: Control group (Normal Saline) (C) (Drug)
结局指标
主要结局
Changes in blood pressure
时间窗: for 8 hours after start of surgery
Blood pressure measurements were performed electronically
Changes in heart rate
时间窗: for 8 hours after start of surgery
Heart rate measurements were performed electronically
次要结局
- Postoperative nausea or vomiting(for 24 hours after start of surgery)
- Postoperative pain score(for 24 hours after start of surgery)
- Occurrence of Oculao-cardiac reflex(for 14 hours after start of surgery)
- Intra-ocular pressure(for 8 hours after start of surgery)