search
Back to results

Gabapentin Pretreatment for Staged Bilateral Cataract Operations

Primary Purpose

Hyperalgesia, Cataract Bilateral Nos

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperalgesia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gabapentin

No medication

Arm Description

Gabapentin premedication group

Control group

Outcomes

Primary Outcome Measures

Pain perception
intraoperative pain perception evaluated by VAS in first and second cataract surgery

Secondary Outcome Measures

Full Information

First Posted
January 30, 2019
Last Updated
November 9, 2020
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03826615
Brief Title
Gabapentin Pretreatment for Staged Bilateral Cataract Operations
Official Title
The Effect of Gabapentin Pretreatment on Hyperalgesia in Elderly Patients Undergoing Staged Bilateral Cataract Operations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia, Cataract Bilateral Nos

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Gabapentin premedication group
Arm Title
No medication
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations
Primary Outcome Measure Information:
Title
Pain perception
Description
intraoperative pain perception evaluated by VAS in first and second cataract surgery
Time Frame
during the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Hwa Seo, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Gabapentin Pretreatment for Staged Bilateral Cataract Operations

We'll reach out to this number within 24 hrs