Controlled Sedation for Cataract Surgery

Phase 4TerminatedNCT03401606

Fundación Universitaria de Ciencias de la Salud98 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Failed Conscious Sedation During Procedure

Interventions

remifentanilDRUG

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

DexmedetomidineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * subject has cataract, * subject older than 18 years, * local anesthesia and sedation. Exclusion Criteria: * general anesthesia, * history of consumption of sedatives.

Outcomes

Primary Outcomes

Surgeon and patient satisfaction

It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges.

Time frame: Intraoperative

Secondary Outcomes

Heart rate

Beats per minute (bpm)

Time frame: Intraoperative

Mean arterial pressure

Millimeters of mercury (mmHg)

Time frame: Intraoperative

Hemoglobin oxygen saturation

Oxygen saturation (%)

Time frame: Intraoperative

Surgery duration

Minutes

Time frame: Intraoperative

Data from ClinicalTrials.gov

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