Prevention of Complications of Eye Surgery (ocr)
|First Received Date ICMJE||May 24, 2007|
|Last Updated Date||May 24, 2007|
|Start Date ICMJE||March 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||incidence of OCR [ Time Frame: TWO YEARS ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||TYPE OF DRUG PREVENTING OCR [ Time Frame: 2 YEARS ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Prevention of Complications of Eye Surgery|
|Official Title ICMJE||phase2 Study of Prevention of Complications of Strabismus Surgery|
This study was designed to investigate pre-operatively measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric strabismus surgery.
Objectives: Despite various proposed maneuver, successfully predicting an oculocardiac reflex (OCR) is difficult to achieve. This study was designed to investigate pre-operatively measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric strabismus surgery.
Methods: Three hundred patients were randomized to one of three anesthetic regimes: group P: propofol (2 mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group K: ketamine (2mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group T: thiopental (5mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction. OCR was defined as a 10% change in heart rate induced by traction.
Results: Incidence of OCR was significantly lower in patients in group k compared with patients in group T or P. Chi-square test results showed that the occurrence of OCR was significantly associated with difference of iris color (P=0.01). The occurrence of the OCR did not correlate with sex, age, duration of surgery, iris color, severity of MGP, number of EOM under tension, and type of mechanical stimulation of eye. Type of mechanical stimulation of eye or number of EOM under tension increased risk of developing OCR by 0.81 (95% CI, 0.66-0.98) and 1.29 (95% CI; 1.12-1.63) respectively.
Conclusions: Induction of anesthesia with ketamine is associated with least hemodynamic changes induced by OCR during strabismus surgery. The prediction of oculocardiac reflex propensity remains elusive.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Intervention ICMJE||Drug: KETAMINE, PROPOFOL, THIOPENTAL|
|Study Arm (s)||Not Provided|
|Publications *||Apivor D, Ravi PK. Ketamine and the oculocardiac reflex. Dysrhythmia in pediatric strabismus surgery: the role of intravenous atropine. Anaesthesia. 1976 Jan-Feb;31(1):18-22.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||2 Years to 18 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Iran, Islamic Republic of|
|Removed Location Countries|
|NCT Number ICMJE||NCT00478907|
|Other Study ID Numbers ICMJE||82390|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Isfahan University of Medical Sciences|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Isfahan University of Medical Sciences|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP