Safety and Efficacy of Propofol Only Sedation in Oral and Maxillofacial Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01227174
Recruitment Status : Unknown
Verified October 2010 by Atlantic Center for Oral and Maxillofacial Surgery.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Information provided by:
Atlantic Center for Oral and Maxillofacial Surgery

Brief 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.

Condition or disease Intervention/treatment Phase
Procedural Sedation Propofol Drug: Propofol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 169 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Propofol Only Sedation in Oral and Maxillofacial Surgery
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Propofol sedation
Patients will be undergo procedural sedation using propofol.
Drug: Propofol
Procedural sedation will be achieved using propofol
Other Name: Diprivan

Primary Outcome Measures :
  1. Pre-Sedation Behavioral Sate [ Time Frame: Pre-operative assessment by RN the day of surgery just prior to entering the operating room. ]
    Patient will complete Corah anxiety scale.

  2. Efficacy of Sedation [ Time Frame: Monitored using a post-operative questionnaire administered 30 minutes after arrival to the recovery room. ]
    The patient does not have unpleasant recall of the procedure.

  3. Adverse outcome [ Time Frame: 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. ]
    Patient will be monitored for: apnea, aspiration, vomiting, cardiovascular events, excitatory movements, paradoxical response

  4. Adverse outcomes [ Time Frame: The patient will be monitored the recovery room in a continuous fashion for 30 minutes. ]
    Unpleasant recovery reactions, permanent complications.

  5. Patient Satisfaction [ Time Frame: 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. ]
    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.

  6. Level of sedation [ Time Frame: This will be measured every 5 minutes throughout the duration of the procedural sedation. ]
    The Ramsay sedation scale will be used to grade the depth of sedation during the procedure.

  7. Surgeon satisfaction [ Time Frame: Immediately after completing the surgical procedure. ]
    The surgeon will complete a 5 point likert scale to determine their level of satisfaction.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ASA Class I and II patients between the ages of 16 to 50 years scheduled to have their third molars extracted under intravenous sedation.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01227174

Contact: Ben Davis, DDS FRCD(C) 902 473 2070
Contact: James Brady, DDS BSc 902 473 7914

Canada, Nova Scotia
Atlantic Centre for Oral and Maxillofacial Surgery 1278 Tower Rd. Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Ben Davis, DDS FRCD(C)    902 473 2070   
Contact: James Brady    902 473 7914   
Principal Investigator: Ben Davis, DDS FRCD(C)         
Sub-Investigator: James Brady, DDS BSc         
Sponsors and Collaborators
Atlantic Center for Oral and Maxillofacial Surgery
Principal Investigator: Ben Davis, DDS FRCD(C) Staff Surgeon at "Atlantic Centre for Oral and Maxillofacial Surgery"

Publications of Results:
Responsible Party: Dr. Ben Davis, Atlantic Centre for Oral and Maxillofacial Surgery Identifier: NCT01227174     History of Changes
Other Study ID Numbers: CDHA-RS/2011-142
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by Atlantic Center for Oral and Maxillofacial Surgery:
propofol only
safety and efficacy

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General