Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/07/2016
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

Dr B Hedayati

ORCID ID

Contact details

Anaesthetics
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
+44 (0)151 604 7056
babak.hedayati@btconnect.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0280123688

Study information

Scientific title

Perioperative anxiety: a comparison between diazepam and propranolol

Acronym

Study hypothesis

Both drugs are anxiolytic, but propranolol should not cause cognitive/psychomotor dysfunction postoperatively, possibly allowing earlier patient discharge

Ethics approval

Not provided at time of registration

Study design

Prospective randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Perioperative anxiety

Intervention

Patients undergoing surgery will be randomised to receive
1. Diazepam
2. Propranolol

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Preoperative anxiety - Hospital Anxiety and Depression Score (HADS) and Visual Analogue Scale (VAS)
2. Pulse/blood pressure - postoperatively
3. VAS - postoperative nausea, vomiting, pain, sedation and satisfaction
4. Tests of cognitive/psychomotor dysfunction - postoperative

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2003

Overall trial end date

31/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

80 inpatients

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

80

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/08/2003

Recruitment end date

31/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics
Wirral
CH49 5PE
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

Wirral Hospitals 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

11/07/2016: No publications found, study status unverified