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OpenTrials
Completed

NCT Number: NCT03143244

Dexmedetomidine vs. Ketorolac/ Midazolam for 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.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine group (D)

Drug

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

Ketorolac-Midazolam group (KM)

Drug

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.

Control group (Normal Saline) (C)

Drug

Patients received normal saline in two sets

Primary outcomes

  1. Changes in blood pressure

    Time frame: for 8 hours after start of surgery

    Blood pressure measurements were performed electronically

  2. Changes in heart rate

    Time frame: for 8 hours after start of surgery

    Heart rate measurements were performed electronically

Secondary outcomes

  1. Intra-ocular pressure

    Time frame: for 8 hours after start of surgery

    Intra-ocular pressure was measured using tonometry technique

  2. Occurrence of Oculao-cardiac reflex

    Time frame: for 14 hours after start of surgery

    Number of patients experienced intraoperative occulo-cardiac reflex

  3. Postoperative nausea or vomiting

    Time frame: for 24 hours after start of surgery

    Number of patients experienced postoperative nausea or vomiting

  4. Postoperative pain score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 8, 2017
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.