Dexmedetomidine vs. Ketorolac/ Midazolam for Retinal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Retinal Surgery
• Intervention / Treatment: Drug: Dexmedetomidine group (D); Drug: Ketorolac-Midazolam group (KM); Drug: Control group (Normal Saline) (C)

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dexmedetomidine 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	Drug: Dexmedetomidine 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
ACTIVE_COMPARATOR: Ketorolac-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.	Drug: Ketorolac-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.
PLACEBO_COMPARATOR: Control group (Normal Saline) (C); Patients received same volume of normal slaine in two sets.	Drug: Control group (Normal Saline) (C); Patients received normal saline in two sets

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Enas A Abd el Motlb, MD, Assisitant Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): November 29, 2016
• Study Completion (ACTUAL): November 30, 2016

Study Registration Dates

• First Submitted: April 15, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine; Ketorolac
• Other Study ID Numbers: MS/15.12.26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No