Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia

Not Applicable

Completed

• Conditions: Cataract; Sedation
• Interventions: Drug: Cataract surgery

• Registration Number: NCT04149340
• Lead Sponsor: University of Liege

Brief Summary

Check the sedation conditions during topic cataract surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-07-01
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-04
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-03
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Topic cataract surgery

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo sedation	Cataract surgery	1 ml de NaCl 0,9%
Sufentanil sedation	Cataract surgery	3 microgram of Sufentanil IV
Multimodal sedation	Cataract surgery	Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine

Primary Outcome Measures

Name	Time	Method
Patient's satisfaction: four Lickert's scales	During cataract surgery	The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)

Secondary Outcome Measures

Name	Time	Method
Surgeon's satisfaction: four Lickert's scales	During cataract surgery	The surgeons's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)
hemodynamic parameters	Durinf cataract surgery	The hemodynamic parameters was rated before incision, 10min after incision and at the end of surgery

Trial Locations

Locations (1)

University of Liege, University Hospital; 🇧🇪 Liège, Belgium