NCT03826615

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

January 30, 2019

Last Update Submit

November 9, 2020

Conditions

HyperalgesiaCataract Bilateral Nos

Outcome Measures

Primary Outcomes (1)

  • Pain perception

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

    during the operation

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin premedication group

Drug: Gabapentin

No medication

NO INTERVENTION

Control group

Interventions

GabapentinDRUG

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

Gabapentin

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HyperalgesiaCataract

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jeong-Hwa Seo, MD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

February 1, 2019

Primary Completion

January 3, 2020

Study Completion

January 3, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

KR(1)