Back to resultsControlled Sedation for Cataract Surgery
Primary Purpose
Failed Conscious Sedation During Procedure
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
remifentanil
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Failed Conscious Sedation During Procedure focused on measuring sedation, dexmedetomidine, remifentanil, cataract surgery, surgeon satisfaction, patient satisfaction
Eligibility Criteria
Inclusion Criteria:
- subject has cataract,
- subject older than 18 years,
- local anesthesia and sedation.
Exclusion Criteria:
- general anesthesia,
- history of consumption of sedatives.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Remifentanil
Dexmedetomidine
Arm Description
remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.
dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Heart rate
Beats per minute (bpm)
Mean arterial pressure
Millimeters of mercury (mmHg)
Hemoglobin oxygen saturation
Oxygen saturation (%)
Surgery duration
Minutes
Full Information
NCT ID
NCT03401606
First Posted
December 14, 2015
Last Updated
January 16, 2018
Sponsor
Fundación Universitaria de Ciencias de la Salud
1. Study Identification
Unique Protocol Identification Number
NCT03401606
Brief Title
Controlled Sedation for Cataract Surgery
Official Title
Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
a respiratory depression in remifentanyl group
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
October 30, 2015 (Actual)
Study Completion Date
January 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Universitaria de Ciencias de la Salud
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Conscious Sedation During Procedure
Keywords
sedation, dexmedetomidine, remifentanil, cataract surgery, surgeon satisfaction, patient satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
Intervention Type
Drug
Intervention Name(s)
remifentanil
Intervention Description
remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
Primary Outcome Measure Information:
Title
Surgeon and patient satisfaction
Description
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 Outcome Measure Information:
Title
Heart rate
Description
Beats per minute (bpm)
Time Frame
Intraoperative
Title
Mean arterial pressure
Description
Millimeters of mercury (mmHg)
Time Frame
Intraoperative
Title
Hemoglobin oxygen saturation
Description
Oxygen saturation (%)
Time Frame
Intraoperative
Title
Surgery duration
Description
Minutes
Time Frame
Intraoperative
Other Pre-specified Outcome Measures:
Title
Hypotension
Description
Systolic blood pressure below 90 mmHg
Time Frame
Intraoperative
Title
Respiratory depression
Description
Decreased respiratory rate below 10 rpm and desaturation, situation that required intubation
Time Frame
Intraoperative
Title
Oxygen desaturation
Description
Hemoglobin oxygen saturation below 90%
Time Frame
Intraoperative
Title
Internation
Description
Inpatient treatment
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subject has cataract,
subject older than 18 years,
local anesthesia and sedation.
Exclusion Criteria:
general anesthesia,
history of consumption of sedatives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Muñoz, Md
Organizational Affiliation
Fundacion universitaria de ciencias de la salud
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Controlled Sedation for Cataract Surgery
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