Overview

Dexmedetomidine Sedation With Third Molar Surgery

Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
Summary
Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom teeth removed. The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital operating rooms and has been approved by the US Food and Drug Administration for the use planned in this study.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Treatments:
Dexmedetomidine
Ketamine
Midazolam
Criteria
Inclusion Criteria:

- American Society of Anesthesiology (ASA) physical status I and II

- Four asymptomatic third molars indicated for removal

Exclusion Criteria:

- Clinical history or ECG evidence of:

- cardiac dysrhythmia or heart block

- ischemic heart disease

- asthma

- sleep apnea

- impaired liver, renal, or mental function

- chronic sedative or analgesic use

- allergies to any of the study drugs

- history of pericoronal infection with third molars