Trial Outcomes & Findings for Dexmedetomidine Sedation With Third Molar Surgery (NCT NCT01017237)

NCT ID: NCT01017237

Last Updated: 2013-06-17

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 18 participants
• Primary outcome timeframe: Day of surgery prior to discharge
• Results posted on: 2013-06-17

Participant Flow

Patients requiring extraction of third molars requiring sedation in the Oral Surgery clinic recruited.

Participant milestones

Measure	Dex Plus Midazolam 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. 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.	Dex Plus Midazolam and Ketamine 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. 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.
Overall Study STARTED	10	8
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexmedetomidine Sedation With Third Molar Surgery

Baseline characteristics by cohort

Measure	Dex Plus Midazolam n=10 Participants 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. 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.	Dex Plus Midazolam and Ketamine n=8 Participants 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. 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.	Total n=18 Participants Total of all reporting groups
Age Continuous	19 years STANDARD_DEVIATION 3.6 • n=5 Participants	20 years STANDARD_DEVIATION 4.1 • n=7 Participants	19 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery prior to discharge

Population: Randomized per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Picture Recall Shown Prior to Sedation.	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: One day after surgery

Population: Per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.	0 percentage of patients	0 percentage of patients

PRIMARY outcome

Timeframe: Day of Surgery prior to discharge

Population: Per protocol

Percentage of patients unable to recall picture

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.	100 percentage of patients	100 percentage of patients

PRIMARY outcome

Timeframe: One day after surgery

Population: per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.	100 percentage of patients	100 percentage of patients

PRIMARY outcome

Timeframe: Day of Surgery prior to discharge

Population: per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery	100 percentage of patients	100 percentage of patients

PRIMARY outcome

Timeframe: One day after surgery

Population: per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.	100 percentage of patients	100 percentage of patients

PRIMARY outcome

Timeframe: Day of Surgery prior to discharge

Population: per protocol

Lack of recall of picture shown indicates presence of amnesia

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery	83 percentage of patients	100 percentage of patients

PRIMARY outcome

Timeframe: One day after surgery

Population: Per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.	83 percentage of patients	100 percentage of patients

PRIMARY outcome

Timeframe: Day of surgery prior to discharge

Population: per protocol

Lack of recall of picture shown indicates presence of amnesia

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Picture Recall at Surgery End Time.	83 percentage of patients	100 percentage of patients

PRIMARY outcome

Timeframe: One day after surgery

Population: per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.	83 percentage of patients	100 percentage of patients

SECONDARY outcome

Timeframe: Immediately prior to sedation

Population: Randomized per protocol

Respirations per minute

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Respiratory Parameters: Respiratory Rate	15 Breaths per Minute Standard Deviation 3	17.2 Breaths per Minute Standard Deviation 4

SECONDARY outcome

Timeframe: During surgical procedure

Population: per protocol

Rate of respirations

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Respiratory Parameters: Respiratory Rate	15 Breaths per Minute Standard Deviation 3	19 Breaths per Minute Standard Deviation 4

SECONDARY outcome

Timeframe: Immediately prior to surgery

Population: per protocol

Oxyhemoglobin saturation per pule oximeter

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Respiratory Parameters: Oxyhemoglobin Saturation	98 Percent oxyhemoglobin saturation Standard Deviation 2.5	98 Percent oxyhemoglobin saturation Standard Deviation 2.4

SECONDARY outcome

Timeframe: During surgical procedure

Population: per protocol

Oxyhemoglobin saturation per pulse oximetry

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Respiratory Parameters: Oxyhemoglobin Saturation	98 Percent oxyhemoglobin saturation Standard Deviation 2.5	98 Percent oxyhemoglobin saturation Standard Deviation 3.4

SECONDARY outcome

Timeframe: Immediately prior to sedation

Population: per protocol

Measured via capnography at nares

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Respiratory Parameters: End-tidal Carbon Dioxide	39.4 mmHg Standard Deviation 4.7	36.2 mmHg Standard Deviation 5.3

SECONDARY outcome

Timeframe: Duration of surgery

Population: per protocol

Measured by capnography at nares

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Respiratory Parameters: End-tidal Carbon Dioxide	36.9 mmHg Standard Deviation 5.1	38.2 mmHg Standard Deviation 4.76

SECONDARY outcome

Timeframe: Immediately prior to surgery

Population: per protocol

Blood pressure per automated monitor

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Mean Arterial Blood Pressure	96.2 mmHg Standard Deviation 12.4	96.4 mmHg Standard Deviation 15.3

SECONDARY outcome

Timeframe: During duration of surgery

Population: per protocol

Measured using automated blood pressure monitor

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Mean Arterial Blood Pressure	93.8 mmHg Standard Deviation 21.2	95.9 mmHg Standard Deviation 18.9

SECONDARY outcome

Timeframe: Prior to sedation

Population: per protocol

Heart rate per EKG monitor

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Heart Rate	66.8 Beats per minute Standard Deviation 11.2	71.4 Beats per minute Standard Deviation 18.4

SECONDARY outcome

Timeframe: Duration of surgery

Population: per protocol

Per EKG monitor

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Heart Rate	75 Beats per minute Standard Deviation 12.4	85.6 Beats per minute Standard Deviation 15.1

SECONDARY outcome

Timeframe: After surgery completed: day of surgery, within 15 minutes

Population: per protocol

Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Surgeon Satisfaction With Sedation Technique	4.0 units on a scale Standard Deviation 0.4	3.2 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: after completion of surgery (within 15 minutes)

Population: per protocol

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

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Patient Satisfaction With Sedation Technique	4.7 units on a scale Standard Deviation 0.2	4.8 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: During surgical procedure

Population: per protocol

Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Ramsey Sedation Scale Score	3.2 units on a scale Standard Deviation 0.4	3.5 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: During surgery duration.

Population: per protocol

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.

Outcome measures

Measure	Dexmedetomidine Plus Midazolam n=5 Participants 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. 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.	Dexmedetomidine Plus Midazolam and Ketamine n=6 Participants 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. 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.
Bispectral Index Score (BIS)	75.1 units on a scale Standard Deviation 11.2	82.6 units on a scale Standard Deviation 12.4

Adverse Events

Dex Plus Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dex Plus Midazolam and Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jay Anderson, DDS, MD

University of North Carolina School of Dentistry

Phone: 919-966-1126

Email: janderson@aims.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place