Retinal Surgery
Conditions
Brief summary
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
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
Interventions
DRUGDexmedetomidine 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
DRUGKetorolac-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.
Patients received normal saline in two sets
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood pressure | for 8 hours after start of surgery | Blood pressure measurements were performed electronically |
| Changes in heart rate | for 8 hours after start of surgery | Heart rate measurements were performed electronically |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-ocular pressure | for 8 hours after start of surgery | Intra-ocular pressure was measured using tonometry technique |
| Occurrence of Oculao-cardiac reflex | for 14 hours after start of surgery | Number of patients experienced intraoperative occulo-cardiac reflex |
| Postoperative nausea or vomiting | for 24 hours after start of surgery | Number of patients experienced postoperative nausea or vomiting |
| Postoperative pain score | for 24 hours after start of surgery | Numerical pain score ( for 24 hours after start of surgery) 0: non 1-3: mild 4-7: moderate 8-10: severe |
Outcome results
None listed