Clinical trial NCT03143244: Dexmedetomidine vs. Ketorolac/ Midazolam for Retinal Surgery
Official title: Dexmedetomidine Versus Ketorolac/ Midazolam on Perioperative Outcome During Retinal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in blood pressure
timeFrame: for 8 hours after start of surgery
measure: Changes in heart rate
timeFrame: for 8 hours after start of surgery
Secondary outcomes:
measure: Intra-ocular pressure
timeFrame: for 8 hours after start of surgery
measure: Occurrence of Oculao-cardiac reflex
timeFrame: for 14 hours after start of surgery
measure: Postoperative nausea or vomiting
timeFrame: for 24 hours after start of surgery
measure: Postoperative pain score
timeFrame: for 24 hours after start of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Assisitant Professor
name: Enas A Abd el Motlb, MD
role: STUDY_DIRECTOR
References: