UnknownPhase 4

Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Anxious Patients

United Kingdom60 participantsStarted 2006-10

Plain-language summary

Whether patient-maintained sedation (the patient controls his/her degree of sedation using a hand-held device) using the drug propofol is safer and more effective when using deteriorating reaction time as an added safeguard against the potential for over sedation in a groups of patients undergoing oral surgery, general dentistry and colonoscopy.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I or II (healthy or mild systemic illness) undergoing planned dental surgery or colonoscopy. * Age 18 - 65 Exclusion Criteria: * ASA III or above * Out with age group above * Contraindication to propofol * History of epilepsy * History of substance abuse * Major Psychiatric illness * Pregnancy or breastfeeding * Unable or unwilling to give informed consent * Unable to use necessary apparatus * Vulnerable groups

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Minimal Sedation Level obtained (modified Objective Observers's Assessment of Sedation)

(Scores 5, fully awake to 1, unresponsive)

Maximal change in oxygen saturation (SpO2)

Trial details

NCT IDNCT00355693

SponsorUniversity of Glasgow

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

Sonia Allam, MB ChB FRCA

0141 211 4625 soniaallam@yahoo.com

View on ClinicalTrials.gov More Oral Surgical Procedures trials