Prevention of Complications of Eye Surgery (ocr)
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|ClinicalTrials.gov Identifier: NCT00478907|
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : May 25, 2007
|Condition or disease||Intervention/treatment||Phase|
|Strabismus||Drug: KETAMINE, PROPOFOL, THIOPENTAL||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||phase2 Study of Prevention of Complications of Strabismus Surgery|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||March 2006|
- incidence of OCR [ Time Frame: TWO YEARS ]
- TYPE OF DRUG PREVENTING OCR [ Time Frame: 2 YEARS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478907
|Iran, Islamic Republic of|
|Tehran, Isfahan, Iran, Islamic Republic of|
|Study Chair:||mohammad safavi, phd||isfahan committee of research|
|Principal Investigator:||hasan soltani, phd||feiz hospital|