Fasting versus non-fasting intravenous sedation in the dental setting
Recruiting
- Conditions
- Intravenous sedation in the dental settingOral Health
- Registration Number
- ISRCTN13385593
- Lead Sponsor
- The Queen's Medical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 732
Inclusion Criteria
1. NHS patients at Edinburgh Dental Institute (EDI) and Chalmers Dental Centre (CDC) planned to undergo oral surgery procedure under intravenous sedation
2. Aged 17-65
3. Classified as ASA I or ASA II
4. Male and female patients
5. Able to give consent
Exclusion Criteria
1. Patients having general anaesthesia
2. Patients having procedures under local anaesthetic alone
3. Patient not able to give consent
4. ASA 3 and ASA 4
5. Patient not willing to participate
6. Patient unable to undertake sedation under midazolam
7. Patients unable to fast e.g. patients with type 1 diabetes mellitus or eating disorders
8. Patients taking St John’s Wort
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of pre-operative (cannulation), intra-operative and post-operative (recovery) complications following intravenous sedation procedures, recorded using the Case Report Form on the day of the operation and until the time of discharge of the patient upon recovery
- Secondary Outcome Measures
Name Time Method 1. Dose of drug used (midazolam), recorded using the Case Report Form on the day of the operation <br>2. Recovery time, recorded using the Case Report Form at the time of discharge of the patient upon recovery