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

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.

Study Overview

• Status: Unknown
• Conditions: Propofol; Procedural Sedation
• Intervention / Treatment: Drug: Propofol

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
• Enrollment (Anticipated): 169
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ben Davis, DDS FRCD(C); Phone Number: 902 473 2070; Email: bdavis@dal.ca
• Study Contact Backup: Name: James Brady, DDS BSc; Phone Number: 902 473 7914; Email: jrbrady@dal.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Atlantic Centre for Oral and Maxillofacial Surgery 1278 Tower Rd.
      • Contact: Ben Davis, DDS FRCD(C); Phone Number: 902 473 2070; Email: bdavis@dal.ca
      • Contact: James Brady; Phone Number: 902 473 7914; Email: jrbrady@dal.ca
      • Principal Investigator: Ben Davis, DDS FRCD(C)
      • Sub-Investigator: James Brady, DDS BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol sedation; Patients will be undergo procedural sedation using propofol.	Drug: Propofol; Procedural sedation will be achieved using propofol; Other Names: Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
Adverse outcomes	Unpleasant recovery reactions, permanent complications.	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.	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.	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.	Immediately after completing the surgical procedure.

Collaborators and Investigators

• Sponsor: 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"

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: October 16, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 21, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: safety and efficacy; propofol only
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: CDHA-RS/2011-142