Gabapentin Pretreatment for Staged Bilateral Cataract Ope... | NCT03826615

Studies
Gabapentin Pretreatment for Staged Bilateral Cataract Operations

NCT03826615

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Nov 12, 2020Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Hyperalgesia
Cataract Bilateral Nos

Interventions

Gabapentin

Countries

South Korea

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

Nov 2020

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

Feb 1, 2019Actual

Primary Completion Date

Jan 3, 2020Actual

Completion Date

Jan 3, 2020Actual

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Jan 31, 2019

First Posted Date

Feb 1, 2019Actual

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

Nov 9, 2020

Last Update Posted Date

Nov 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

To evaluate the effect of oral gabapentin premedication on hyperalgesia in elderly patients undergoing staged bilateral cataract operations under monitored anesthesia care

Detailed Description

It has been reported that patients with bilateral cataract complained more pain and discomfort during the second consecutive eye surgery compared to the first eye surgery.

Gabapentin is an anticonvulsant drug, which has been extended the use to perioperative analgesia, and anxiolysis.

Therefore, the investigators conducted this randomized, controlled study to evaluate the effects of gabapentin premedication on patients' subjective sensations, including intraoperative anxiety, perceptions of pain, and light sensitivity, in the second cataract operations.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin	Experimental	Gabapentin premedication group	Drug: Gabapentin
No medication	No Intervention	Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations	Gabapentin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain perception	intraoperative pain perception evaluated by VAS in first and second cataract surgery	during the operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged over 60 years, who undergoing staged bilateral cataract operations under monitored anesthesia care
ASA physical status of I, II, and III

Exclusion Criteria:

undergoing other eye operations together besides cataract operation
patients with creatinin clearance lower than 30ml/min
patients with CNS inhibitors medication
patients with previous gabapentin medication
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeong-Hwa Seo, MD	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006930	Hyperalgesia
D002386	Cataract

Ancestor Terms

ID	Term
D020886	Somatosensory Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided