Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436146696
Study information
Scientific title
Acronym
Study hypothesis
1. To determine whether the use of capnography in adults consciously sedated with intravenous midazolam for dental treatment can reduce the incidence of fall in arterial oxygen haemoglobin saturation as measured by pulse oximetry.
2. To report on the effect of the use of supplemental oxygen on alveolar carbon dioxide as measured by capnography.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Oral Health
Intervention
Capnography vs no capnography
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2004
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Adults (18 years old and over) on the dental treatment waiting list at the sedation unit at the Leeds Dental Institute.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
15-20
Participant exclusion criteria
Patients not fulfulling the criteria for inclusion.
Recruitment start date
01/02/2004
Recruitment end date
01/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dental Department
Leeds
LS2 9LU
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding
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