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Controlled Sedation for Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401606
Recruitment Status : Terminated (a respiratory depression in remifentanyl group)
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación Universitaria de Ciencias de la Salud

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

Condition or disease Intervention/treatment Phase
Failed Conscious Sedation During Procedure Drug: remifentanil Drug: Dexmedetomidine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : October 30, 2015
Actual Study Completion Date : January 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Surgeon and patient satisfaction [ Time Frame: Intraoperative ]
    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.


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: Intraoperative ]
    Beats per minute (bpm)

  2. Mean arterial pressure [ Time Frame: Intraoperative ]
    Millimeters of mercury (mmHg)

  3. Hemoglobin oxygen saturation [ Time Frame: Intraoperative ]
    Oxygen saturation (%)

  4. Surgery duration [ Time Frame: Intraoperative ]
    Minutes


Other Outcome Measures:
  1. Hypotension [ Time Frame: Intraoperative ]
    Systolic blood pressure below 90 mmHg

  2. Respiratory depression [ Time Frame: Intraoperative ]
    Decreased respiratory rate below 10 rpm and desaturation, situation that required intubation

  3. Oxygen desaturation [ Time Frame: Intraoperative ]
    Hemoglobin oxygen saturation below 90%

  4. Internation [ Time Frame: Intraoperative ]
    Inpatient treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • general anesthesia,
  • history of consumption of sedatives.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401606


Sponsors and Collaborators
Fundación Universitaria de Ciencias de la Salud
Investigators
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Study Director: Luis Muñoz, Md Fundacion universitaria de ciencias de la salud
More Information
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Responsible Party: Fundación Universitaria de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT03401606    
Other Study ID Numbers: 516-3847-33
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Fundación Universitaria de Ciencias de la Salud:
sedation
dexmedetomidine
remifentanil
 cataract surgery
surgeon satisfaction
patient satisfaction
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics