Trial Outcomes & Findings for A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation (NCT NCT03255824)

Results Overview

To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

144 participants

Primary outcome timeframe

During surgery

Results posted on

2020-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Propofol Group Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination. Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.	Dexmedetomidine Group Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination. Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
Overall Study STARTED	69	75
Overall Study COMPLETED	67	74
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Propofol Group Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination. Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.	Dexmedetomidine Group Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination. Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
Overall Study Under-sedation	2	1

Baseline Characteristics

Race/Ethnicity Not Collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol Group n=69 Participants Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination. Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.	Dexmedetomidine Group n=75 Participants Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination. Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.	Total n=144 Participants Total of all reporting groups
Age, Continuous	21.3 years STANDARD_DEVIATION 2.7 • n=69 Participants	21.4 years STANDARD_DEVIATION 2.5 • n=75 Participants	21.4 years STANDARD_DEVIATION 2.7 • n=144 Participants
Sex: Female, Male Female	50 Participants n=69 Participants	46 Participants n=75 Participants	96 Participants n=144 Participants
Sex: Female, Male Male	19 Participants n=69 Participants	29 Participants n=75 Participants	48 Participants n=144 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants Race/Ethnicity Not Collected	0 Participants Race/Ethnicity Not Collected	0 Participants Race/Ethnicity Not Collected
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants Race/Ethnicity Not Collected	0 Participants Race/Ethnicity Not Collected	0 Participants Race/Ethnicity Not Collected
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants Race/Ethnicity Not Collected	0 Participants Race/Ethnicity Not Collected	0 Participants Race/Ethnicity Not Collected
Body Mass Index (BMI)	25.3 kg/m^2 STANDARD_DEVIATION 5.2 • n=69 Participants	26.1 kg/m^2 STANDARD_DEVIATION 5.4 • n=75 Participants	25.7 kg/m^2 STANDARD_DEVIATION 5.4 • n=144 Participants
Number of Impactions	3.6 Impacted Teeth STANDARD_DEVIATION 0.5 • n=69 Participants	3.6 Impacted Teeth STANDARD_DEVIATION 0.5 • n=75 Participants	3.6 Impacted Teeth STANDARD_DEVIATION 0.5 • n=144 Participants

PRIMARY outcome

Timeframe: During surgery

To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.

Outcome measures

Outcome measures
Measure	Propofol Group n=67 Participants Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination. Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.	Dexmedetomidine Group n=74 Participants Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination. Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
Respiratory Events Requiring Intervention	17 Participants	2 Participants

SECONDARY outcome

Timeframe: During the first injection of local anesthesia during surgery

To compare the groups regarding movement of the patient during the first injection of local anesthesia during the IVS at time of injection measured using the Behavioral Pain Scale - Non-Intubated patients. The minimum value is 3 and the maximum value is 12. Higher scores mean a worse outcome (i.e., more pain and movement on injection)

Outcome measures

Outcome measures
Measure	Propofol Group n=67 Participants Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination. Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.	Dexmedetomidine Group n=74 Participants Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination. Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
Reaction to Administration of Local Anesthesia	3.9 score on a scale Standard Deviation 1.5	4.2 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 30 minutes following surgery

Visual Analog Scale was used to measure overall satisfaction with the IV sedation and memory of the procedure. The minimum score is 0 (not satisfied at all) to a maximum score of 100 (completely satisfied). A higher score is a better outcome.

Outcome measures

Outcome measures
Measure	Propofol Group n=67 Participants Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination. Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.	Dexmedetomidine Group n=74 Participants Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination. Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
Patient Satisfaction	93.5 score on a scale Standard Deviation 10.1	86.6 score on a scale Standard Deviation 22.0

SECONDARY outcome

Timeframe: 15 minutes following surgery

Surgeon satisfaction was measured by the surgeon grading the "Operating Conditions" scale. The minimum value was 0 and the maximum was 3. 0=very poor, 1=poor, 2=fair, 3=good

Outcome measures

Outcome measures
Measure	Propofol Group n=67 Participants Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination. Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.	Dexmedetomidine Group n=74 Participants Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination. Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
Surgeon Satisfaction - Survey	2.8 score on a scale Standard Deviation 0.5	2.9 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: 15 minutes following surgery

Surgeon satisfaction is measured by the Cooperation Scale. Minimum score of 0 and maximum of 9. Higher indicates a worse outcome (i.e., discomfort and movement)