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Completed

NCT Number: NCT03826615

Gabapentin Pretreatment for Staged Bilateral Cataract Operations

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

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Key information

Conditions

Hyperalgesia Cataract Cataract Bilateral Nos Eye Diseases Lens Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

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

Primary outcomes

  1. Pain perception

    Time frame: during the operation

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2019
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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