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Spinal Anesthesia - Intraocular Pressure

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. Identifier: NCT02061644
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : April 7, 2014
Information provided by (Responsible Party):
Ruslan Abdullayev, Adiyaman University Research Hospital

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE February 13, 2014
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Number of the patients with changed intraocular pressure [ Time Frame: One month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02061644 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Spinal Anesthesia - Intraocular Pressure
Official Title  ICMJE Intraocular Pressure Changes After Spinal Anesthesia: Acute and Subacute Effects
Brief Summary We aim to investigate the effect of spinal anesthesia on intraocular pressure.
Detailed Description

Spinal anesthesia provides adequate anesthetic conditions for many operations. These operations include orthopedic, urological, gynecological and many general surgery operations. Although few, side effects of the procedure and its effects on body are well known. However, there is inadequate knowledge about the effects of spinal anesthesia on pressure changes in the eyes. These pressure changes in eyes can result in some detriments. Elevated pressures in the eyes can result in disease known as glaucoma, that makes hazard to eyes. Decreased eye pressures can also result in some eye detriments.

We aimed to investigate the effects of spinal anesthesia procedure on eye (intraocular) pressure changes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Intraocular Pressure
Intervention  ICMJE Other: Spinal anesthesia
Routine spinal anesthesia procedure will be made to the patients for surgical anesthesia.
Study Arms  ICMJE Experimental: Spinal
Spinal anesthesia for surgical procedure will be applied to the patients. Intraocular pressures will be measured before and after the procedure.
Intervention: Other: Spinal anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients having general surgery operations under umbilicus
  • patients of American Society of Anesthesiologists (ASA) status I-II

Exclusion Criteria:

  • patients denying spinal anesthesia
  • contraindications for spinal anesthesia
  • eye diseases
  • hypertension
  • ASA status III or more
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02061644
Other Study ID Numbers  ICMJE Spinal-IOP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ruslan Abdullayev, Adiyaman University Research Hospital
Study Sponsor  ICMJE Adiyaman University Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruslan Abdullayev, Dr Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation, Adiyaman City, Turkey.
PRS Account Adiyaman University Research Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP