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Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Isfahan University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417572
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Isfahan University of Medical Sciences
  Purpose
The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.

Condition Intervention Phase
Retinal Detachment Drug: lidocaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • intraoperative heart rate measurement [ Time Frame: 6 month ]
  • decrease in pain and nausea,vomiting after surgery [ Time Frame: 6 month ]
  • decrease in ocr after application of topical lidocaine [ Time Frame: 6 month ]
  • postoperative nausea and vommitting [ Time Frame: 6 month ]
  • postoperative pain [ Time Frame: 6 month ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: September 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine Drug: lidocaine
to evaluate the effect of lidocaine on oculocardiac reflex during the surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Retinal detachment
  • Retinal tear less than 3 hour clock

Exclusion Criteria:

  • Vitreous hemorrhage
  • Proliferative vitreoretinopathy
  Contacts and Locations
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): NCT01417572


Contacts
Contact: Amin Masjedi, MD +983112211915 Masjedi1827@gmail.com

Locations
Iran, Islamic Republic of
Isfahan University of Medical Sciences Recruiting
Isfahan, Iran, Islamic Republic of, 7864329800
Contact: amin masjedi, MD    +983112211915    Masjedi1827@gmail.com   
Principal Investigator: Amin Masjedi, MD         
Sponsors and Collaborators
Isfahan University of Medical Sciences
  More Information

Responsible Party: isfahan university of medical sciences
ClinicalTrials.gov Identifier: NCT01417572     History of Changes
Other Study ID Numbers: 199
First Submitted: August 9, 2011
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
Last Verified: January 2010

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action