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

NCT ID: NCT01227174

Last Updated: 2010-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Propofol sedation

Patients will be undergo procedural sedation using propofol.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Procedural sedation will be achieved using propofol

Interventions

Propofol

Procedural sedation will be achieved using propofol

Intervention Type: DRUG

Other Intervention Names

Diprivan

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantic Center for Oral and Maxillofacial Surgery

OTHER

Sponsor Role: lead

Responsible Party

Atlantic Centre for Oral and Maxillofacial Surgery

Principal Investigators

Ben Davis, DDS FRCD(C)

Role: PRINCIPAL_INVESTIGATOR

Staff Surgeon at "Atlantic Centre for Oral and Maxillofacial Surgery"

Locations

Atlantic Centre for Oral and Maxillofacial Surgery 1278 Tower Rd.

Halifax, Nova Scotia, Canada

Countries

Canada

Central Contacts

Ben Davis, DDS FRCD(C)

Role: CONTACT

bdavis@dal.ca

902 473 2070

James Brady, DDS BSc

Role: CONTACT

jrbrady@dal.ca

902 473 7914

Facility Contacts

Ben Davis, DDS FRCD(C)

Role: primary

bdavis@dal.ca

902 473 2070

James Brady

Role: backup

jrbrady@dal.ca

902 473 7914

References

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.

Reference Type: RESULT

PMID: 18072987 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19845550 (View on PubMed)

Other Identifiers

CDHA-RS/2011-142

Identifier Type: -

Identifier Source: org_study_id