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Clinical Trials/NCT04149340
NCT04149340CompletedNot Applicable

Comparison of Two Sedation Versus Placebo Techniques on the Patient's Intraoperative Comfort During Cataract Surgery Under Local Anesthesia

University of Liege1 site in 1 country300 target enrollmentStarted: June 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Benjamin Javillier

Principal Investigator

University of Liege

Study Sites (1)

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