Trial Outcomes & Findings for Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block (NCT NCT02469961)

NCT ID: NCT02469961

Last Updated: 2024-11-13

Results Overview

airway manipulation or repositioning: apnea, oral airway, adjust head

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr
• Results posted on: 2024-11-13

Participant Flow

Participant milestones

Measure	Dexmedetomidne Participants will receive an interscalene block and be sedated with dexmedetomidine Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol Interscalene block: Interscalene block is used for the main anesthetic for the case	Propofol Participants will receive an interscalene block and be sedated with propofol Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme Interscalene block: Interscalene block is used for the main anesthetic for the case
Overall Study STARTED	25	25
Overall Study COMPLETED	21	24
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Dexmedetomidne Participants will receive an interscalene block and be sedated with dexmedetomidine Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol Interscalene block: Interscalene block is used for the main anesthetic for the case	Propofol Participants will receive an interscalene block and be sedated with propofol Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme Interscalene block: Interscalene block is used for the main anesthetic for the case
Overall Study Physician Decision	4	1

Baseline Characteristics

Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block

Baseline characteristics by cohort

Measure	Dexmedetomidine n=21 Participants Participants will receive an interscalene block and be sedated with dexmedetomidine Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol Interscalene block: Interscalene block is used for the main anesthetic for the case	Propofol n=24 Participants Participants will receive an interscalene block and be sedated with propofol Propofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine Interscalene block: Interscalene block is used for the main anesthetic for the case	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr

airway manipulation or repositioning: apnea, oral airway, adjust head

Outcome measures

Measure	Dexmedetomidine n=21 Participants Number of patients required airway manipulation	Propofol n=24 Participants Number of patients required airway manipulations
Number of Participants That Need an Airway Intervention.	0 participants	5 participants

SECONDARY outcome

Timeframe: Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation

length of stay in minutes in the Post Anesthesia Care Unit before discharge

Outcome measures

Measure	Dexmedetomidine n=21 Participants Number of patients required airway manipulation	Propofol n=24 Participants Number of patients required airway manipulations
Post Anesthesia Care Unit (PACU) Length of Stay	159 Minutes Standard Deviation 12	126 Minutes Standard Deviation 12

SECONDARY outcome

Timeframe: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr

Population: Number of patients who had Bradycardia or hypotension

Number of participants observed with Bradycardia or Hypotension who required intervention

Outcome measures

Measure	Dexmedetomidine n=24 Participants Number of patients required airway manipulation	Propofol n=21 Participants Number of patients required airway manipulations
Number of Participants That Have Either Bradycardia or Hypotension	4 participants	5 participants

SECONDARY outcome

Timeframe: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr

the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents

Outcome measures

Measure	Dexmedetomidine n=21 Participants Number of patients required airway manipulation	Propofol n=24 Participants Number of patients required airway manipulations
Total Narcotic Used by Each Participant	7.1 Microgram Standard Deviation 23.9	9 Microgram Standard Deviation 24.2

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol

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

Piyush Gupta, Director of clinical affairs

Maimonides Medical Center

Phone: 718-283-7189

Email: pgupta@maimonidesmed.org

Results disclosure agreements

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