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Gabapentin Pretreatment for Staged Bilateral Cataract Operations

NCT ID: NCT03826615

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-01-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyperalgesia Cataract Bilateral Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Gabapentin

Gabapentin premedication group

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations

No medication

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gabapentin

Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Hwa Seo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Hwa Seo, MD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JHSeo_gabapentin

Identifier Type: -

Identifier Source: org_study_id