Dexmedetomidine vs. Ketorolac/ Midazolam for Retinal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Dexmedetomidine Versus Ketorolac/ Midazolam on Perioperative Outcome During Retinal Surgery.

Conditions
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Retinal Surgery

Intervention / Treatment
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* Drug: Dexmedetomidine group (D)
* Drug: Ketorolac-Midazolam group (KM)
* Drug: Control group (Normal Saline) (C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status |or || Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine group (D)<br>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 | Drug: Dexmedetomidine group (D)<br>* 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<br>|
| Active Comparator: Ketorolac-Midazolam group (KM)<br>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. | Drug: Ketorolac-Midazolam group (KM)<br>* 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.<br>|
| Placebo Comparator: Control group (Normal Saline) (C)<br>Patients received same volume of normal slaine in two sets. | Drug: Control group (Normal Saline) (C)<br>* Patients received normal saline in two sets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure | Blood pressure measurements were performed electronically | for 8 hours after start of surgery | 
| Changes in heart rate | Heart rate measurements were performed electronically | for 8 hours after start of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-ocular pressure | Intra-ocular pressure was measured using tonometry technique | for 8 hours after start of surgery | 
| Occurrence of Oculao-cardiac reflex | Number of patients experienced intraoperative occulo-cardiac reflex | for 14 hours after start of surgery | 
| Postoperative nausea or vomiting | Number of patients experienced postoperative nausea or vomiting | 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 | for 24 hours after start of surgery |