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Fasting versus non-fasting intravenous sedation in the dental setting

Fasting versus non-fasting prior to intravenous sedation in the dental setting: a single-blinded randomised trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13385593
Enrollment
732
Registered
2017-08-11
Start date
2017-09-18
Completion date
Unknown
Last updated
2017-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravenous sedation in the dental setting Oral Health

Interventions

The patient information sheet for this project is sent with the letter for the new patient appointment. Then when the patients are seen in the Edinburgh Dental Institute or the Chalmers Dental Centre

Sponsors

The Queen's Medical Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Dose of drug used (midazolam), recorded using the Case Report Form on the day of the operation 2. Recovery time, recorded using the Case Report Form at the time of discharge of the patient upon recovery

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026