NCT04149340CompletedNot Applicable
Comparison of Two Sedation Versus Placebo Techniques on the Patient's Intraoperative Comfort During Cataract Surgery Under Local Anesthesia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Liege
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Patient's satisfaction: four Lickert's scales
Study Overview
Brief Summary
Check the sedation conditions during topic cataract surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Topic cataract surgery
Exclusion Criteria
- Not provided
Arms & Interventions
Sufentanil sedation
Other
3 microgram of Sufentanil IV
Intervention: Cataract surgery (Drug)
Placebo sedation
Placebo Comparator
1 ml de NaCl 0,9%
Intervention: Cataract surgery (Drug)
Multimodal sedation
Other
Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine
Intervention: Cataract surgery (Drug)
Outcomes
Primary Outcomes
Patient's satisfaction: four Lickert's scales
Time Frame: During cataract surgery
The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
Secondary Outcomes
- Surgeon's satisfaction: four Lickert's scales(During cataract surgery)
- hemodynamic parameters(Durinf cataract surgery)
Investigators
Benjamin Javillier
Principal Investigator
University of Liege
Study Sites (1)
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