Gabapentin Pretreatment for Staged Bilateral Cataract Operations

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03826615

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperalgesia Cataract Bilateral Nos	Drug: Gabapentin	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Jan 3, 2020

Actual Study Completion Date :

Jan 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin Gabapentin premedication group	Drug: Gabapentin Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations
No Intervention: No medication Control group

Arm

Intervention/Treatment

Experimental: Gabapentin

Gabapentin premedication group

Drug: Gabapentin

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

No Intervention: No medication

Control group

Outcome Measures

Primary Outcome Measures

Pain perception [during the operation]
intraoperative pain perception evaluated by VAS in first and second cataract surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Study Chair: Jeong-Hwa Seo, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong-Hwa Seo, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03826615

Other Study ID Numbers:

JHSeo_gabapentin

First Posted:

Feb 1, 2019

Last Update Posted:

Nov 12, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperalgesia

Cataract

Gabapentin

Study Results

No Results Posted as of Nov 12, 2020