Procedural SedationPhase 4NCT01227174
Safety and Efficacy of Propofol Only Sedation in Oral and Maxillofacial Surgery
A Phase 4 study testing Propofol in people with Procedural Sedation and Propofol, run by Atlantic Center for Oral and Maxillofacial Surgery at 1 site in Canada.
Trial summary
The purpose of this study is to determine if the use of propofol only to achieve procedural sedation for the removal of third molars is both safe and effective. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation, Propofol
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ASA Class I and II patients between the ages of 16 to 50 years scheduled to have their third molars extracted under intravenous sedation.
Who cannot join
- history of psychiatric illness, chronic use of central nervous system depressants or antidepressants, or alcohol abuse, had an active infection with systemic symptoms, were morbidly obese, were pregnant, or had a positive history of anesthetic-related complications.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Atlantic Centre for Oral and Maxillofacial Surgery 1278 Tower Rd.
Halifax, Nova Scotia, B3H 2Y9
Ben Davis, DDS FRCD(C), 902 473 2070, bdavis@dal.ca
James Brady, 902 473 7914, jrbrady@dal.ca
About this study
The purpose of this study is to determine if the use of propofol only to achieve procedural sedation for the removal of third molars is both safe and effective.
Read the detailed description
Removal of third molars is a common procedure performed in North America. Many surgeon choose to complete the procedure using procedural sedation. The most commonly used combination of medications to achieve procedural sedation consists of midazolam, fentanyl, and propofol. Propofol has been gaining increasing attention as a sedative agent due to its predictable pharmacokinetics and favorable amnestic properties. These properties make propofol an attractive sedative agent when compared to the benzodiazepines which are known to have a slower onset coupled with a much longer offset resulting in a prolonged sedative effect well beyond that required for completion of the procedure. Several studies have compared the use of propofol in combination with other sedatives with various control groups. These studies reliably confirm both the safety and efficacy of propofol. Some researches have speculated that the differences in nausea and vomiting reported by patients are secondary to the differences in dosage of fentanyl between groups. Others have concluded that fentanyl provides no advantage when using intermittent propofol in short duration procedures. Recent studies have found favourable results when using propofol only to achieve procedural sedation. On review of the Oral and Maxillofacial Surgery literature regarding this topic, a lack of internally and externally validated research was discovered. Oral and Maxillofacial surgical procedures are unique in duration of procedure and use of local anesthesia making it difficult to generalize data obtained from other specialties.
All eligible patients will be assigned to a single group. They will be asked to fill out a survey to determine their level of anxiety prior to the procedure. Participants will then proceed the same as non-study patients to see the nurse for a pre-operative assessment. After seeing the nurse, patients will see the surgeon for the procedure. Most of the data (blood pressure, heart rate, breathing rate etc.) is collected during the procedure. During procedural sedation monitoring is performed as usual but study patients will have capnometry added to the standard of care. Capnometry is a way of examining your breathing. It is the measurement of the carbon dioxide in the air that you breathe out through you nose. After the procedure is complete patients are transported to recovery where they must remain for a minimum of 30 minutes prior to discharge. The nurse in recovery will monitor you recovery continuously during your stay. The nurse will also apply a standard recovery score to your recovery every 5 minutes to track your progression. Once you are recovered from the procedural sedation you will be asked to complete a short questionnaire about your procedural sedation experience. After discharge patients will be contacted by phone 24 to 48 hours later to review a final questionnaire.
- Conditions
- Procedural Sedation, Propofol
- Being tested
- Propofol
- Keywords
- propofol only, safety and efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Procedural sedation will be achieved using propofol
| Study group | Role | What they receive |
|---|---|---|
| Propofol sedation | Experimental | Patients will be undergo procedural sedation using propofol. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Sedation Behavioral Sate
Patient will complete Corah anxiety scale.
Measured: Pre-operative assessment by RN the day of surgery just prior to entering the operating room.
Efficacy of Sedation
The patient does not have unpleasant recall of the procedure.
Measured: Monitored using a post-operative questionnaire administered 30 minutes after arrival to the recovery room.
Adverse outcome
Patient will be monitored for: apnea, aspiration, vomiting, cardiovascular events, excitatory movements, paradoxical response
Measured: Throughout the procedural sedation in a continuous fashion. The start time of the procedural sedation will be defined as the time of the first dose of propofol and the stop time will be the time that the patient is transferred to recovery.
Adverse outcomes
Unpleasant recovery reactions, permanent complications.
Measured: The patient will be monitored the recovery room in a continuous fashion for 30 minutes.
Patient Satisfaction
A questionnaire will be given to the patient to complete just prior to discharge. The patient will be contacted 24 to 48 hours after discharge to complete a second questionnaire.
Measured: This will be measured 30 minutes after arrival to the recovery room and then once again via phone questionnaire between 24 to 48 hours after discharge.
Level of sedation
The Ramsay sedation scale will be used to grade the depth of sedation during the procedure.
Measured: This will be measured every 5 minutes throughout the duration of the procedural sedation.
Surgeon satisfaction
The surgeon will complete a 5 point likert scale to determine their level of satisfaction.
Measured: Immediately after completing the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Center for Oral and Maxillofacial Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Ben Davis, DDS FRCD(C), Principal investigator, Staff Surgeon at "Atlantic Centre for Oral and Maxillofacial Surgery"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227174
- Sponsor's protocol ID
- CDHA-RS/2011-142
- Status last verified
- Oct 2010
- First submitted
- 16 Oct 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zed PJ, Abu-Laban RB, Chan WW, Harrison DW. Efficacy, safety and patient satisfaction of propofol for procedural sedation and analgesia in the emergency department: a prospective study. CJEM. 2007 Nov;9(6):421-7. doi: 10.1017/s148180350001544x.
PubMed 18072987Miner JR, Gray RO, Stephens D, Biros MH. Randomized clinical trial of propofol with and without alfentanil for deep procedural sedation in the emergency department. Acad Emerg Med. 2009 Sep;16(9):825-34. doi: 10.1111/j.1553-2712.2009.00487.x.
PubMed 19845550