Clinical trial NCT01017237: Dexmedetomidine Sedation With Third Molar Surgery
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Dexmedetomidine sedation
Oral surgery sedation
Dexmedetomidine amnesia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg. All of the above parameters will again be obtained and recorded. Patients will be randomly assigned by block randomization to receive either midazolam 0.04 mg/kg i.v. (50 patients), or midazolam 0.04 mg/kg plus 0.25 mg/kg of ketamine (50 patients). The operating surgeon and the patient will be blinded as to which protocol is being used. A dexmedetomidine infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery. At this point local anesthesia will be administered in all four quadrants. Pain reaction during injections will be recorded. When efficacy of local anesthesia has been confirmed, surgery will commence. The surgery will be interrupted at 15 and 30 minutes to show a picture for recall testing by an investigator. If at any point the patient is deemed to be uncomfortable or uncooperative due to inadequate sedation, the protocol will be broken and additional sedation administered as per usual standards. The rescue therapy may include additional midazolam, ketamine, narcotic or propofol at the discretion of the anesthetist/sedationist. At the conclusion of surgery the dexmedetomidine infusion will be discontinued and the patient will be attended by a recovery nurse for collection of postoperative data. During recovery the physiologic parameters will be recorded at 10 minute intervals. When the patient achieves a recovery Aldrete score of \>9, they will be asked by an investigator to recall pictures for amnesia assessment, and asked to assess patient satisfaction before leaving with an escort. The patient will be contacted on the day following surgery by phone or e-mail by one of the investigators to test for recall of pictures shown (amnesia testing) and patient satisfaction

Eligibility 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

Primary outcomes:
measure: Amnesia: Lack of Picture Recall Shown Prior to Sedation.
timeFrame: Day of surgery prior to discharge
measure: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.
timeFrame: One day after surgery
measure: Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.
timeFrame: Day of Surgery prior to discharge
measure: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.
timeFrame: One day after surgery
measure: Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery
timeFrame: Day of Surgery prior to discharge
measure: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.
timeFrame: One day after surgery
measure: Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery
timeFrame: Day of Surgery prior to discharge
measure: Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.
timeFrame: One day after surgery
measure: Amnesia: Lack of Picture Recall at Surgery End Time.
timeFrame: Day of surgery prior to discharge
measure: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.
timeFrame: One day after surgery
Secondary outcomes:
measure: Respiratory Parameters: Respiratory Rate
timeFrame: Immediately prior to sedation
measure: Respiratory Parameters: Respiratory Rate
timeFrame: During surgical procedure
measure: Respiratory Parameters: Oxyhemoglobin Saturation
timeFrame: Immediately prior to surgery
measure: Respiratory Parameters: Oxyhemoglobin Saturation
timeFrame: During surgical procedure
measure: Respiratory Parameters: End-tidal Carbon Dioxide
timeFrame: Immediately prior to sedation
measure: Respiratory Parameters: End-tidal Carbon Dioxide
timeFrame: Duration of surgery
measure: Mean Arterial Blood Pressure
timeFrame: Immediately prior to surgery
measure: Mean Arterial Blood Pressure
timeFrame: During duration of surgery
measure: Heart Rate
timeFrame: Prior to sedation
measure: Heart Rate
timeFrame: Duration of surgery
measure: Surgeon Satisfaction With Sedation Technique
timeFrame: After surgery completed: day of surgery, within 15 minutes
measure: Patient Satisfaction With Sedation Technique
timeFrame: after completion of surgery (within 15 minutes)
measure: Ramsey Sedation Scale Score
timeFrame: During surgical procedure
measure: Bispectral Index Score (BIS)
timeFrame: During surgery duration.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Dentistry
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Jay A Anderson, DDS, MD
role: PRINCIPAL_INVESTIGATOR
References: