Dexmedetomidine Sedation With Third Molar Surgery

Anesthesia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01017237
• Other study ID #: 08-2157
• Status: Terminated
• Phase: Phase 4
• First received: August 14, 2009
• Last updated: May 7, 2013
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Dexmedetomidine
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.
• Midazolam
Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.
• Ketamine
Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.

Locations

Country	Name	City	State
United States	University of North Carolina School of Dentistry	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.	Percentage of patients unable to recall picture	Day of Surgery prior to discharge	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Respiratory Parameters: Respiratory Rate	Respirations per minute	Immediately prior to sedation	Yes
Secondary	Respiratory Parameters: Respiratory Rate	Rate of respirations	During surgical procedure	Yes
Secondary	Respiratory Parameters: Oxyhemoglobin Saturation	Oxyhemoglobin saturation per pule oximeter	Immediately prior to surgery	Yes
Secondary	Respiratory Parameters: Oxyhemoglobin Saturation	Oxyhemoglobin saturation per pulse oximetry	During surgical procedure	Yes
Secondary	Respiratory Parameters: End-tidal Carbon Dioxide	Measured via capnography at nares	Immediately prior to sedation	Yes
Secondary	Respiratory Parameters: End-tidal Carbon Dioxide	Measured by capnography at nares	Duration of surgery	Yes
Secondary	Mean Arterial Blood Pressure	Blood pressure per automated monitor	Immediately prior to surgery	Yes
Secondary	Mean Arterial Blood Pressure	Measured using automated blood pressure monitor	During duration of surgery	Yes
Secondary	Heart Rate	Heart rate per EKG monitor	Prior to sedation	Yes
Secondary	Heart Rate	Per EKG monitor	Duration of surgery	Yes
Secondary	Surgeon Satisfaction With Sedation Technique	Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)	After surgery completed: day of surgery, within 15 minutes	No
Secondary	Patient Satisfaction With Sedation Technique	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	after completion of surgery (within 15 minutes)	No
Secondary	Ramsey Sedation Scale Score	Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive	During surgical procedure	No
Secondary	Bispectral Index Score (BIS)	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.	During surgery duration.	No