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

October 3, 2020 updated by: Benjamin Javillier, University of Liege

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

Check the sedation conditions during topic cataract surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • University of Liege, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Topic cataract surgery

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Sufentanil sedation
3 microgram of Sufentanil IV
Drug: Cataract surgery
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
PLACEBO_COMPARATOR: Placebo sedation
1 ml de NaCl 0,9%
Drug: Cataract surgery
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
OTHER: Multimodal sedation
Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine
Drug: Cataract surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During cataract surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

October 17, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (ACTUAL)

November 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 3, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANESCATARACT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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