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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
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Strabismus Drug: KETAMINE, PROPOFOL, THIOPENTAL Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: phase2 Study of Prevention of Complications of Strabismus Surgery
Study Start Date : March 2004
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine




Primary Outcome Measures :
  1. incidence of OCR [ Time Frame: TWO YEARS ]

Secondary Outcome Measures :
  1. TYPE OF DRUG PREVENTING OCR [ Time Frame: 2 YEARS ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Iran, Islamic Republic of
Feiz Hospital
Tehran, Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Study Chair: mohammad safavi, phd isfahan committee of research
Principal Investigator: hasan soltani, phd feiz hospital
Additional Information:
Publications:
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ClinicalTrials.gov Identifier: NCT00478907    
Other Study ID Numbers: 82390
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007
Keywords provided by Isfahan University of Medical Sciences:
oculocardiac reflex; strabismus surgery;
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Ketamine
Thiopental
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
GABA Modulators
GABA Agents