Controlled Sedation for Cataract Surgery

Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation

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

Study Overview

• Status: Terminated
• Conditions: Failed Conscious Sedation During Procedure
• Intervention / Treatment: Drug: remifentanil; Drug: Dexmedetomidine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• general anesthesia,
• history of consumption of sedatives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remifentanil; remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.	Drug: remifentanil; remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished
Active Comparator: Dexmedetomidine; dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished	Drug: Dexmedetomidine; dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Beats per minute (bpm)	Intraoperative
Mean arterial pressure	Millimeters of mercury (mmHg)	Intraoperative
Hemoglobin oxygen saturation	Oxygen saturation (%)	Intraoperative
Surgery duration	Minutes	Intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension	Systolic blood pressure below 90 mmHg	Intraoperative
Respiratory depression	Decreased respiratory rate below 10 rpm and desaturation, situation that required intubation	Intraoperative
Oxygen desaturation	Hemoglobin oxygen saturation below 90%	Intraoperative
Internation	Inpatient treatment	Intraoperative

Collaborators and Investigators

• Sponsor: Fundación Universitaria de Ciencias de la Salud
• Investigators: Study Director: Luis Muñoz, Md, Fundación Universitaria de Ciencias de la Salud

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): October 30, 2015
• Study Completion (Actual): January 30, 2016

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: dexmedetomidine; sedation; cataract surgery; patient satisfaction; remifentanil; surgeon satisfaction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: 516-3847-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No