Back to resultsComparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia
Primary Purpose
Sedation, Cataract
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Sedation
Eligibility Criteria
Inclusion Criteria:
- Topic cataract surgery
Exclusion Criteria:
- NA
Sites / Locations
- University of Liege, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Placebo Comparator
Other
Arm Label
Sufentanil sedation
Placebo sedation
Multimodal sedation
Arm Description
3 microgram of Sufentanil IV
1 ml de NaCl 0,9%
Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine
Outcomes
Primary Outcome Measures
Patient's satisfaction: four Lickert's scales
The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
Secondary Outcome Measures
Surgeon's satisfaction: four Lickert's scales
The surgeons's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
hemodynamic parameters
The hemodynamic parameters was rated before incision, 10min after incision and at the end of surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04149340
Brief Title
Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia
Official Title
Comparison of Two Sedation Versus Placebo Techniques on the Patient's Intraoperative Comfort During Cataract Surgery Under Local Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Check the sedation conditions during topic cataract surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sufentanil sedation
Arm Type
Other
Arm Description
3 microgram of Sufentanil IV
Arm Title
Placebo sedation
Arm Type
Placebo Comparator
Arm Description
1 ml de NaCl 0,9%
Arm Title
Multimodal sedation
Arm Type
Other
Arm Description
Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine
Intervention Type
Drug
Intervention Name(s)
Cataract surgery
Intervention Description
Patient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery
Primary Outcome Measure Information:
Title
Patient's satisfaction: four Lickert's scales
Description
The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
Time Frame
During cataract surgery
Secondary Outcome Measure Information:
Title
Surgeon's satisfaction: four Lickert's scales
Description
The surgeons's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
Time Frame
During cataract surgery
Title
hemodynamic parameters
Description
The hemodynamic parameters was rated before incision, 10min after incision and at the end of surgery
Time Frame
Durinf cataract surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Topic cataract surgery
Exclusion Criteria:
NA
Facility Information:
Facility Name
University of Liege, University Hospital
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
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Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia
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