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

Ketamine

Brief Summary

Check the sedation conditions during topic cataract surgery

Intervention / Treatment

  • Cataract surgery (DRUG)
    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

Condition or Disease

  • Sedation
  • Cataract

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 95 Years
    Enrollment: 300 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Investigator

    Clinical Trial Dates

    Start date: Jun 01, 2019 ACTUAL
    Primary Completion: Jul 01, 2019 ACTUAL
    Completion Date: Dec 31, 2019 ACTUAL
    Study First Posted: Nov 04, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 03, 2020

    Sponsors / Collaborators

    Lead Sponsor: University of Liege
    Responsible Party: N/A

    Location

    Liège, Belgium

    Participant Groups

    • 3 microgram of Sufentanil IV

    • 1 ml de NaCl 0,9%

    • Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 95
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Topic cataract surgery

    Exclusion Criteria:

    * NA

    Primary Outcomes

    • The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)

    Secondary Outcomes

    • The surgeons's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome)

    • The hemodynamic parameters was rated before incision, 10min after incision and at the end of surgery

    More Details

    NCT Number: NCT04149340
    Other IDs: ANESCATARACT
    Study URL: https://clinicaltrials.gov/study/NCT04149340
    Last updated: Sep 29, 2023