NCT04149340

Brief Summary

Check the sedation conditions during topic cataract surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 17, 2019

Last Update Submit

October 3, 2020

Conditions

SedationCataract

Outcome Measures

Primary Outcomes (1)

  • Patient's satisfaction: four Lickert's scales

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

    During cataract surgery

Secondary Outcomes (2)

  • Surgeon's satisfaction: four Lickert's scales

    During cataract surgery

  • hemodynamic parameters

    Durinf cataract surgery

Study Arms (3)

Sufentanil sedation

OTHER

3 microgram of Sufentanil IV

Drug: Cataract surgery

Placebo sedation

PLACEBO COMPARATOR

1 ml de NaCl 0,9%

Drug: Cataract surgery

Multimodal sedation

OTHER

Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine

Drug: Cataract surgery

Interventions

Cataract surgeryDRUG

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

Multimodal sedationPlacebo sedationSufentanil sedation

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Topic cataract surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liege, University Hospital

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2019

First Posted

November 4, 2019

Study Start

June 1, 2019

Primary Completion

July 1, 2019

Study Completion

December 31, 2019

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

BE(1)