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Prevention of Complications of Eye Surgery (ocr)

Primary Purpose

Strabismus

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
KETAMINE, PROPOFOL, THIOPENTAL
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Strabismus focused on measuring oculocardiac reflex; strabismus surgery;

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Feiz Hospital

Outcomes

Primary Outcome Measures

incidence of OCR

Secondary Outcome Measures

TYPE OF DRUG PREVENTING OCR

Full Information

First Posted
May 24, 2007
Last Updated
May 24, 2007
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00478907
Brief Title
Prevention of Complications of Eye Surgery
Acronym
ocr
Official Title
phase2 Study of Prevention of Complications of Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
Keywords
oculocardiac reflex; strabismus surgery;

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
KETAMINE, PROPOFOL, THIOPENTAL
Primary Outcome Measure Information:
Title
incidence of OCR
Time Frame
TWO YEARS
Secondary Outcome Measure Information:
Title
TYPE OF DRUG PREVENTING OCR
Time Frame
2 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammad safavi, phd
Organizational Affiliation
isfahan committee of research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
hasan soltani, phd
Organizational Affiliation
feiz hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feiz Hospital
City
Tehran
State/Province
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
1259120
Citation
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. doi: 10.1111/j.1365-2044.1976.tb11740.x.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Search&db=pubmed&term=oculocardiac+reflex+ketamine&tool=fuzzy&ot=oculocardac+reflex+ketamine
Description
oculocardiac reflex ketamine

Learn more about this trial

Prevention of Complications of Eye Surgery

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