Dexmedetomidine Sedation With Third Molar Surgery

NCT01017237 | Terminated Phase 4 Results

• 1 other identifier: 08-2157
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

Dexmedetomidine sedation; Oral surgery sedation; Dexmedetomidine amnesia

Outcome Measures

Primary Outcomes (10)

• Amnesia: Lack of Picture Recall Shown Prior to Sedation.

  Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery

  Day of surgery prior to discharge

• Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.

  Lack of recall of picture shown indicates presence of amnesia the day following surgery.

  One day after surgery

• Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.

  Percentage of patients unable to recall picture

  Day of Surgery prior to discharge

• Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.

  Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.

  One day after surgery

• Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery

  Lack of recall of picture shown at this time indicates presence of amnesia

  Day of Surgery prior to discharge

• Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.

  Lack of recall of picture demonstrates presence of amnesia on day following surgery

  One day after surgery

• Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery

  Lack of recall of picture shown indicates presence of amnesia

  Day of Surgery prior to discharge

• Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.

  Lack of recall of picture shown indicates presence of amnesia on day following surgery.

  One day after surgery

• Amnesia: Lack of Picture Recall at Surgery End Time.

  Lack of recall of picture shown indicates presence of amnesia

  Day of surgery prior to discharge

• Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.

  Lack of recall of picture shown indicates presence of amnesia on day following surgery.

  One day after surgery

Secondary Outcomes (14)

• Respiratory Parameters: Respiratory Rate

  Immediately prior to sedation

• Respiratory Parameters: Respiratory Rate

  During surgical procedure

• Respiratory Parameters: Oxyhemoglobin Saturation

  Immediately prior to surgery

• Respiratory Parameters: Oxyhemoglobin Saturation

  During surgical procedure

• Respiratory Parameters: End-tidal Carbon Dioxide

  Immediately prior to sedation

Study Arms (2)

Dex plus midazolam

ACTIVE COMPARATOR

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.

Drug: Dexmedetomidine; Drug: Midazolam

Dex plus midazolam and ketamine

ACTIVE COMPARATOR

Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.

Drug: Dexmedetomidine; Drug: Midazolam; Drug: Ketamine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.

Also known as: Precedex

Dex plus midazolam; Dex plus midazolam and ketamine

Midazolam DRUG

Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.

Also known as: Versed

Dex plus midazolam; Dex plus midazolam and ketamine

Ketamine DRUG

Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Also known as: Ketalar

Dex plus midazolam and ketamine

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiology (ASA) physical status I and II
• Four asymptomatic third molars indicated for removal

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Early termination due to ineffective sedation. We had to abandon the protocol in 5 of 10 patients in the dexmedetomidine plus midazolam group and 2 of 8 patients in the dexmedetomidine plus midazolam and ketamine group because of combative behavior.

Results Point of Contact

• Title: Jay Anderson, DDS, MD
• Organization: University of North Carolina School of Dentistry

janderson@aims.unc.edu

919-966-1126

Study Officials

• Jay A Anderson, DDS, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: November 20, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 17, 2013
• Results First Posted: June 17, 2013

Record last verified: 2012-04

Locations

US (1)