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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149340
• Other study ID #: ANESCATARACT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Check the sedation conditions during topic cataract surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Topic cataract surgery

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Cataract
• Sedation

Intervention

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

Locations

Country	Name	City	State
Belgium	University of Liege, University Hospital	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

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