Prevention of Complications of Eye Surgery

Brief Summary

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.

Intervention / Treatment

  • KETAMINE, PROPOFOL, THIOPENTAL (DRUG)
    N/A

Condition or Disease

  • Strabismus

Phase

  • Phase 2
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 2 Years to 18 Years
    Enrollment: 300 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    Clinical Trial Dates

    Start date: Mar 01, 2004
    Primary Completion: Aug 31, 2020
    Completion Date: Mar 01, 2006 ACTUAL
    Study First Posted: May 25, 2007 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 24, 2007

    Sponsors / Collaborators

    Responsible Party: N/A
    No responsible party listed

    Location

    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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 18
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • incidence of OCR TWO YEARS
    Secondary Outcomes
    • TYPE OF DRUG PREVENTING OCR 2 YEARS

    More Details

    NCT Number: NCT00478907
    Acronym: ocr
    Other IDs: 82390
    Study URL: https://clinicaltrials.gov/study/NCT00478907
    Last updated: Sep 29, 2023