Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478907
Status:
COMPLETED
Last Update Posted:
2007-05-25
First Post:
2007-05-24
Brief Title:
Prevention of Complications of Eye Surgery
Sponsor:
Isfahan University of Medical Sciences
Organization:
Isfahan University of Medical Sciences
Study Overview
Official Title:
phase2 Study of Prevention of Complications of Strabismus Surgery
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ocr
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 mgkg alfentanil 002 mgkg and atracurium 05 mgkg at induction group K ketamine 2mgkg alfentanil 002 mgkg and atracurium 05 mgkg at induction group T thiopental 5mgkg alfentanil 002 mgkg and atracurium 05 mgkg 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 P001 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 081 95 CI 066-098 and 129 95 CI 112-163 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
Methods Three hundred patients were randomized to one of three anesthetic regimes group P propofol 2 mgkg alfentanil 002 mgkg and atracurium 05 mgkg at induction group K ketamine 2mgkg alfentanil 002 mgkg and atracurium 05 mgkg at induction group T thiopental 5mgkg alfentanil 002 mgkg and atracurium 05 mgkg 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 P001 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 081 95 CI 066-098 and 129 95 CI 112-163 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None