Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Eugene Tay

ORCID ID

Contact details

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
-
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0141125451

Study information

Scientific title

Effect of intravenous (IV) sedation on patient satisfaction after cataract surgery with topical anaesthesia

Acronym

Study hypothesis

To determine the effect of IV midazolam on patient satisfaction after cataract surgery with topical anaesthesia.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised single masked pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Cataract

Intervention

Randomised to sedation or placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Midazolam

Primary outcome measures

Patient satisfaction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

30 patients for cataract surgery

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

15 for sedation, 15 for placebo

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2003

Recruitment end date

31/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Moorfields Eye Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes