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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
60
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
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.
Patients received normal saline in two sets
Changes in blood pressure
Blood pressure measurements were performed electronically
Time frame: for 8 hours after start of surgery
Changes in heart rate
Heart rate measurements were performed electronically
Time frame: for 8 hours after start of surgery
Intra-ocular pressure
Intra-ocular pressure was measured using tonometry technique
Time frame: for 8 hours after start of surgery
Occurrence of Oculao-cardiac reflex
Number of patients experienced intraoperative occulo-cardiac reflex
Time frame: for 14 hours after start of surgery
Postoperative nausea or vomiting
Number of patients experienced postoperative nausea or vomiting
Time frame: for 24 hours after start of surgery
Postoperative pain score
Numerical pain score ( for 24 hours after start of surgery) 0: non 1-3: mild 4-7: moderate 8-10: severe
Time frame: for 24 hours after start of surgery
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