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

Propofol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01227174
• Other study ID #: CDHA-RS/2011-142
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 16, 2010
• Last updated: October 21, 2010
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2010
• Source: Atlantic Center for Oral and Maxillofacial Surgery
• Contact: Ben Davis, DDS FRCD(C)
• Phone: 902 473 2070
• Email: bdavis[@]dal.ca
• Is FDA regulated: No
• Health authority: Canada: Atlantic Centre for Oral and Maxillofacial Surgery
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 169
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Procedural Sedation
• Propofol

Intervention

Drug:
• Propofol
Procedural sedation will be achieved using propofol

Locations

Country	Name	City	State
Canada	Atlantic Centre for Oral and Maxillofacial Surgery 1278 Tower Rd.	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Center for Oral and Maxillofacial Surgery

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Miner 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Sedation Behavioral Sate	Patient will complete Corah anxiety scale.	Pre-operative assessment by RN the day of surgery just prior to entering the operating room.	No
Primary	Efficacy of Sedation	The patient does not have unpleasant recall of the procedure.	Monitored using a post-operative questionnaire administered 30 minutes after arrival to the recovery room.	No
Primary	Adverse outcome	Patient will be monitored for: apnea, aspiration, vomiting, cardiovascular events, excitatory movements, paradoxical response	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.	Yes
Primary	Adverse outcomes	Unpleasant recovery reactions, permanent complications.	The patient will be monitored the recovery room in a continuous fashion for 30 minutes.	Yes
Primary	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.	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.	No
Primary	Level of sedation	The Ramsay sedation scale will be used to grade the depth of sedation during the procedure.	This will be measured every 5 minutes throughout the duration of the procedural sedation.	No
Primary	Surgeon satisfaction	The surgeon will complete a 5 point likert scale to determine their level of satisfaction.	Immediately after completing the surgical procedure.	No