Clinical Trial: Dexmedetomidine Sedation With Third Molar Surgery

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Comparison of the Effectiveness of Sedation With i.v. Dexmedetomidine in Combination With Midazolam Alone or Midazolam and Low Dose Ketamine for Extraction of Third Molars.

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.

Detailed Summary:

Subjects who have been screened medically and are scheduled for third molar surgery in the University of North Carolina (UNC)Oral and Maxillofacial Surgery (OMFS) clinic will be asked to volunteer for the study by the evaluating OMFS resident or attending physician. No additional x-rays will be taken other than those usually indicated for 3rd molar surgery. Informed consent will be obtained by study investigators.

Subjects will be instructed to fast for at least 8 hours prior to their appointment. Surgery will be performed in the Oral & Maxillofacial Surgery operating/sedation clinic where all monitoring equipment as well as emergency equipment is readily available, including the ability to ventilate the patient with oxygen (bag-mask), the ability to intubate, resuscitation drugs and equipment including a defibrillator. Patients will be positioned in a semi-reclining position in the dental chair and all monitors applied. A 20 gauge i.v. catheter will be placed and normal saline infusion attached. Supplemental oxygen will be administered via nasal cannula at 3 liters per minute. A picture will then be shown for recall testing. Pulse rate, arterial oxygen saturation (SpO2), respiratory rate, blood pressure, end-tidal CO2 (ETCO2), Ramsey Sedation Score (RSS sedation score) and Bispectral Index Scale (BIS) value will be recorded as a baseline and at 5 minute intervals during the procedure. Any SpO2 values below 90% as well as any episodes of apnea greater than 20 seconds will be recorded. Monitoring and recording of all data will be done by one of the investigators. Data will be recorded on pre-printed data forms. The surgical procedure will be performed by an oral and maxillofacial surgery resident physician.

Following the administration of 0.12 mg/kg of dexamethasone , dexmedetomidine will be infused at a rate of 6 mcg/k
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

• Amnesia: Lack of Picture Recall Shown Prior to Sedation. [ Time Frame: Day of surgery prior to discharge ]
  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
• Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation. [ Time Frame: One day after surgery ]
  Lack of recall of picture shown indicates presence of amnesia the day following surgery.
• Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam. [ Time Frame: Day of Surgery prior to discharge ]
  Percentage of patients unable to recall picture
• Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam. [ Time Frame: One day after surgery ]
  Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.
• Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery [ Time Frame: Day of Surgery prior to discharge ]
  Lack of recall of picture shown at this time indicates presence of amnesia
• Respiratory Parameters: Respiratory Rate [ Time Frame: Immediately prior to sedation ]
  Respirations per minute
• Respiratory Parameters: Respiratory Rate [ Time Frame: During surgical procedure ]
  Rate of respirations
• Respiratory Parameters: Oxyhemoglobin Saturation [ Time Frame: Immediately prior to surgery ]
  Oxyhemoglobin saturation per pule oximeter
• Respiratory Parameters: Oxyhemoglobin Saturation [ Time Frame: During surgical procedure ]
  Oxyhemoglobin saturation per pulse oximetry
• Respiratory Parameters: End-tidal Carbon Dioxide [ Time Frame: Immediately prior to sedation ]
  Measured via capnography at nares
• Respiratory Parameters: End-tidal Carbon Dioxide [ Time Frame: Duration of surgery ]
  Measured by capnography at nares
• Mean Arterial Blood Pressure [ Time Frame: Immediately prior to surgery ]
  Blood pressure per automated monitor
• Mean Arterial Blood Pressure [ Time Frame: During duration of surgery ]
  Measured using automated blood pressure monitor
• Heart Rate [ Time Frame: Prior to sedation ]
  Heart rate per EKG monitor
• Heart Rate [ Time Frame: Duration of surgery ]
  Per EKG monitor
• Surgeon Satisfaction With Sedation Technique [ Time Frame: After surgery completed: day of surgery, within 15 minutes ]
  Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)
• Patient Satisfaction With Sedation Technique [ Time Frame: after completion of surgery (within 15 minutes) ]
  Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied
• Ramsey Sedation Scale Score [ Time Frame: During surgical procedure ]
  Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive
• Bispectral Index Score (BIS) [ Time Frame: During surgery duration. ]
  Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state.

Original Secondary Outcome:

• Respiratory Parameters: Respiratory rate, ETCO2, SpO2 [ Time Frame: Continuous. Recorded every 5 minutes or with any significant deviation from normal. ]
• Cardiovascular Parameters: Heart rate, blood pressure and ECG [ Time Frame: Continuous: Recorded at 5 minute intervals as well as any significant deviations from normal recorded. ]
• Surgeon Satisfaction With Sedation Technique [ Time Frame: After surgery completed: day of surgery, within 15 minutes ]
• Patient Satisfaction With Sedation Technique [ Time Frame: after completion of surgery (within 15 minutes) and the day after surgery (24 hours) ]

Dates:
Date Received: August 14, 2009
Date Started: July 2009
Date Completion:
Last Updated: May 7, 2013
Last Verified: April 2012