Dexmedetomidine vs. Ketorolac/ Midazolam for Retinal Surgery

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Retinal Surgery

Treatments: Drug: Ketorolac-Midazolam group (KM); Drug: Dexmedetomidine group (D); Drug: Control group (Normal Saline) (C)

Study type: Interventional

Funder types: Other

Identifiers

NCT03143244

MS/15.12.26

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Dexmedetomidine group (D)

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine group (D)

Ketorolac-Midazolam group (KM)

Active Comparator group

Description:

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.

Treatment:

Drug: Ketorolac-Midazolam group (KM)

Control group (Normal Saline) (C)

Placebo Comparator group

Description:

Patients received same volume of normal slaine in two sets.

Treatment:

Drug: Control group (Normal Saline) (C)