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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Atlantic Center for Oral and Maxillofacial Surgery.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Atlantic Center for Oral and Maxillofacial Surgery
ClinicalTrials.gov Identifier:
NCT01227174
First received: October 16, 2010
Last updated: October 21, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Procedural Sedation
Propofol
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Propofol Only Sedation in Oral and Maxillofacial Surgery

Resource links provided by NLM:


Further study details as provided by Atlantic Center for Oral and Maxillofacial Surgery:

Primary Outcome Measures:
  • Pre-Sedation Behavioral Sate [ Time Frame: Pre-operative assessment by RN the day of surgery just prior to entering the operating room. ] [ Designated as safety issue: No ]
    Patient will complete Corah anxiety scale.

  • Efficacy of Sedation [ Time Frame: Monitored using a post-operative questionnaire administered 30 minutes after arrival to the recovery room. ] [ Designated as safety issue: No ]
    The patient does not have unpleasant recall of the procedure.

  • 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. ] [ Designated as safety issue: Yes ]
    Patient will be monitored for: apnea, aspiration, vomiting, cardiovascular events, excitatory movements, paradoxical response

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

  • 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. ] [ Designated as safety issue: No ]
    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.

  • Level of sedation [ Time Frame: This will be measured every 5 minutes throughout the duration of the procedural sedation. ] [ Designated as safety issue: No ]
    The Ramsay sedation scale will be used to grade the depth of sedation during the procedure.

  • Surgeon satisfaction [ Time Frame: Immediately after completing the surgical procedure. ] [ Designated as safety issue: No ]
    The surgeon will complete a 5 point likert scale to determine their level of satisfaction.


Estimated Enrollment: 169
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol sedation
Patients will be undergo procedural sedation using propofol.
Drug: Propofol
Procedural sedation will be achieved using propofol
Other Name: Diprivan

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227174

Contacts
Contact: Ben Davis, DDS FRCD(C) 902 473 2070 bdavis@dal.ca
Contact: James Brady, DDS BSc 902 473 7914 jrbrady@dal.ca

Locations
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    bdavis@dal.ca   
Contact: James Brady    902 473 7914    jrbrady@dal.ca   
Principal Investigator: Ben Davis, DDS FRCD(C)         
Sub-Investigator: James Brady, DDS BSc         
Sponsors and Collaborators
Atlantic Center for Oral and Maxillofacial Surgery
Investigators
Principal Investigator: Ben Davis, DDS FRCD(C) Staff Surgeon at "Atlantic Centre for Oral and Maxillofacial Surgery"
  More Information

Publications:
Responsible Party: Dr. Ben Davis, Atlantic Centre for Oral and Maxillofacial Surgery
ClinicalTrials.gov Identifier: NCT01227174     History of Changes
Other Study ID Numbers: CDHA-RS/2011-142
Study First Received: October 16, 2010
Last Updated: October 21, 2010
Health Authority: Canada: Atlantic Centre for Oral and Maxillofacial Surgery

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

Additional relevant MeSH terms:
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 16, 2014