Controlled Sedation for Cataract Surgery

Fundación Universitaria de Ciencias de la Salud

Status and phase: Terminated; Phase 4

Conditions: Failed Conscious Sedation During Procedure

Treatments: Drug: Dexmedetomidine; Drug: remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03401606

516-3847-33

Details and patient eligibility

About

This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

Full description

This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subject has cataract,
• subject older than 18 years,
• local anesthesia and sedation.

Exclusion criteria

• general anesthesia,
• history of consumption of sedatives.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups

Remifentanil

Active Comparator group

Description:

remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.

Treatment:

Drug: remifentanil

Dexmedetomidine

Active Comparator group

Description:

dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished

Treatment:

Drug: Dexmedetomidine