Condition category
Surgery
Date applied
05/05/2010
Date assigned
10/06/2010
Last edited
10/06/2010
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

Prof Daiana Stolz

ORCID ID

Contact details

University Hospital Basel
Clinic for Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 5184
stolzd@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Propofol versus Propofol plus Hydrocodone sedation in flexible bronchoscopy: a prospective, randomised, placebo-controlled, double-blind study

Acronym

PROHYDE Study

Study hypothesis

The combination of propofol and hydrocodone is superior to propofol alone to suppress cough during flexible bronchoscopy.

Ethics approval

Ethics commission of Basel (Ethikkomission beider Basel [EKBB]) approved in on the 2nd of February 2009 (ref: 29/09)

Study design

Randomised placebo controlled double blind intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Sedation for flexible bronchoscopy

Intervention

Patients were randomly assigned to either intravenous propofol or the combination of propofol and hydrocodone (4mg).

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Cough score during the procedure as estimated by the physician using a visual-analogue-scale (VAS)

Secondary outcome measures

1. Total dose of propofol
2. Haemodynamic parameters
3. Patient’s discomfort, assessed 2 hours after procedure
4. Complications during flexible bronchoscopy
5. Patient reported side effects, assessed 24 hours after procedure

Overall trial start date

14/02/2009

Overall trial end date

31/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 18 years
2. Requirement of flexible bronchoscopy
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Tracheal Intubation
2. Known allergy or intolerance to hydrocodone or propofol
3. Mental retardation
4. Pregnancy

Recruitment start date

14/02/2009

Recruitment end date

31/01/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Clinic for Pneumology and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 5184
stolzd@uhbs.ch

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel (Switzerland) - Clinic for Pulmonary Medicine and Respiratory Cell Research

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