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NCT03826615 Clinical Trial

Gabapentin Pretreatment for Staged Bilateral Cataract Operations

Hyperalgesia Clinical Trial

Official title:
The Effect of Gabapentin Pretreatment on Hyperalgesia in Elderly Patients Undergoing Staged Bilateral Cataract Operations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03826615
Other study ID # JHSeo_gabapentin
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date January 3, 2020

Study information
Verified date November 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date January 3, 2020
Est. primary completion date January 3, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain perception intraoperative pain perception evaluated by VAS in first and second cataract surgery during the operation
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