ISRCTN ISRCTN60630970
DOI https://doi.org/10.1186/ISRCTN60630970
Protocol serial number N0280123688
Sponsor Department of Health
Funder Wirral Hospitals NHS Trust (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
11/07/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B Hedayati
Scientific

Anaesthetics
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Phone +44 (0)151 604 7056
Email babak.hedayati@btconnect.com

Study information

Primary study designInterventional
Study designProspective randomised double-blind controlled trial
Secondary study designRandomised controlled trial
Scientific titlePerioperative anxiety: a comparison between diazepam and propranolol
Study objectivesBoth drugs are anxiolytic, but propranolol should not cause cognitive/psychomotor dysfunction postoperatively, possibly allowing earlier patient discharge
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and Behavioural Disorders: Perioperative anxiety
InterventionPatients undergoing surgery will be randomised to receive
1. Diazepam
2. Propranolol
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/07/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexAll
Target sample size at registration80
Key inclusion criteria80 inpatients
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/08/2003
Date of final enrolment31/07/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Anaesthetics
Wirral
CH49 5PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

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