Spinal Anesthesia - Intraocular Pressure | NCT02061644

Studies
Spinal Anesthesia - Intraocular Pressure

NCT02061644

Sponsor

Adiyaman University Research Hospital

Status

Completed

Last Update Posted

Apr 7, 2014Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Intraocular Pressure

Interventions

Spinal anesthesia

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Feb 10, 2014

First Submission Date that Met QC Criteria

Feb 11, 2014

First Posted Date

Feb 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ruslan Abdullayev, Dr. Ruslan Abdullayev, Adiyaman University Research HospitalPrincipal Investigator

Lead Sponsor

Adiyaman University Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spinal	Experimental	Spinal anesthesia for surgical procedure will be applied to the patients. Intraocular pressures will be measured before and after the procedure.	Other: Spinal anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal anesthesia	Other	Routine spinal anesthesia procedure will be made to the patients for surgical anesthesia.	Spinal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of the patients with changed intraocular pressure		One month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruslan Abdullayev, Dr	Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation, Adiyaman City, Turkey.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Adiyaman University Research Hospital		Adıyaman		02000	Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D000775	Anesthesia, Spinal

Ancestor Terms

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided