Prevention of Complications of Eye Surgery (ocr)

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00478907
First received: May 24, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted

May 24, 2007
May 24, 2007
March 2004
Not Provided
incidence of OCR [ Time Frame: TWO YEARS ]
Same as current
No Changes Posted
TYPE OF DRUG PREVENTING OCR [ Time Frame: 2 YEARS ]
Same as current
Not Provided
Not Provided
 
Prevention of Complications of Eye Surgery
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Strabismus
Drug: KETAMINE, PROPOFOL, THIOPENTAL
Not Provided
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.
 
Completed
300
March 2006
Not Provided

Inclusion Criteria:

  • 300 ASA physical status I or II patients, aged 2-18 years, who candidate for elective strabismus surgery

Exclusion Criteria:

  • trauma to eye, ASA III or IV, who had contraindication for using thiopental, ketamine, or propofol, had cardiovascular diseases or had taken cardiovascular drugs
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00478907
82390
No
Not Provided
Isfahan University of Medical Sciences
Not Provided
Study Chair: mohammad safavi, phd isfahan committee of research
Principal Investigator: hasan soltani, phd feiz hospital
Isfahan University of Medical Sciences
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP