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Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Isfahan University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01417572
First received: August 9, 2011
Last updated: August 15, 2011
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

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

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: isfahan university of medical sciences
ClinicalTrials.gov Identifier: NCT01417572     History of Changes
Other Study ID Numbers: 199
Study First Received: August 9, 2011
Last Updated: August 15, 2011
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013