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

NCT01227174 | Unknown Phase 4 DMC

• 1 other identifier: CDHA-RS/2011-142
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation; Propofol

Keywords

propofol only; safety and efficacy

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (1)

Propofol sedation

EXPERIMENTAL

Patients will be undergo procedural sedation using propofol.

Drug: Propofol

Interventions

Propofol DRUG

Procedural sedation will be achieved using propofol

Also known as: Diprivan

Propofol sedation

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlantic Center for Oral and Maxillofacial Surgery: lead

Study Sites (1)

Atlantic Centre for Oral and Maxillofacial Surgery 1278 Tower Rd.

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (2)

• 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.

  PMID: 18072987 RESULT

• 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.

  PMID: 19845550 RESULT

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ben Davis, DDS FRCD(C)

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben Davis, DDS FRCD(C)

CONTACT

902 473 2070; bdavis@dal.ca

James Brady, DDS BSc

CONTACT

902 473 7914; jrbrady@dal.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2010
• First Posted: October 25, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

CA (1)