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

Dexmedetomidine vs Propofol TIVA and Interscalene Block for Shoulder Surgeries in a Beach Chair Sitting Position

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02469961
Acronym
TIVA
Enrollment
50
Registered
2015-06-12
Start date
2010-10-31
Completion date
2012-07-31
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Brief summary

The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for this study. Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Detailed description

The anesthesia provided during shoulder surgery commonly uses a combination of regional and intravenous (IV) anesthetic medications. The current drug of choice for IV sedation is Propofol. Although. it is a good anesthetic, incidence of intermittent apnea makes the use of it problematic in cases where the head of the patient is less accessible to the anesthesiologist, as is in sitting beach char position. Dexmedetomidine is a FDA approved drug, which has a very stable cardiovascular and respiratory profile. It has been successfully used for Neurological and Vascular cases and in Intensive care units. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators' will enroll 50 patients for this study. Using a computer program the participants will be randomized into two equal groups to receive either Dexmedetomidine or Propofol. The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol. Dexmedetomidine infusion is initiated with a bolus of 1 mcg/kg is given over 10 min as patient is being positioned, and the sedation is maintained with Dexmedetomidine at 0.7- 1.0 mcg/kg/hr during the surgery. Propofol infusion is started at 100mcg/kg/min, and maintained with Propofol at 50-120mcg/kg/min, during the surgery. In each group the investigators will record the incidence of respiratory depression/hypoxia, hemodynamic stability, frequency of airway manipulation, cardiovascular effects, need for anesthetic supplementation of Dexmedetomidine, post anesthesia care unit (PACU) discharge time, the need for postoperative pain medication, post operative complications, like nausea/vomiting. Significant differences between the two groups will be evaluated using unpaired t-test for numerical variables, and Chi-square test or Z test for categorical variables. The investigators hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Interventions

DRUGDexmedetomidine

Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol

DRUGPropofol

Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine

OTHERInterscalene block

Interscalene block is used for the main anesthetic for the case

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

Participants scheduled for shoulder arthroscopies in the beach chair sitting position. Participants who received a successful interscalene block.

Exclusion criteria

Failed interscalene block. Refusal to participate in the study. Allergy to the study drugs. Participants that need a secure airway.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants That Need an Airway Intervention.Participants will be followed from the start of sedation until discharge: approximately 3-5 hrairway manipulation or repositioning: apnea, oral airway, adjust head

Secondary

MeasureTime frameDescription
Post Anesthesia Care Unit (PACU) Length of StayArrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operationlength of stay in minutes in the Post Anesthesia Care Unit before discharge
Number of Participants That Have Either Bradycardia or HypotensionParticipants will be followed from the start of sedation until discharge: approximately 3-5 hrNumber of participants observed with Bradycardia or Hypotension who required intervention
Total Narcotic Used by Each ParticipantParticipants will be followed from the start of sedation until discharge: approximately 3-5 hrthe use for morphine and/or fentanyl and or Demerol converted to morphine equivalents

Countries

United States

Participant flow

Participants by arm

ArmCount
Dexmedetomidine
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
21
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 Dexmedetomidine Interscalene block: Interscalene block is used for the main anesthetic for the case
24
Total45

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision41

Baseline characteristics

CharacteristicDexmedetomidinePropofolTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
21 Participants24 Participants45 Participants
Sex: Female, Male
Female
9 Participants13 Participants22 Participants
Sex: Female, Male
Male
12 Participants11 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 210 / 24
serious
Total, serious adverse events
0 / 210 / 24

Outcome results

Primary

Number of Participants That Need an Airway Intervention.

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

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

ArmMeasureValue (NUMBER)
DexmedetomidineNumber of Participants That Need an Airway Intervention.0 participants
PropofolNumber of Participants That Need an Airway Intervention.5 participants
Secondary

Number of Participants That Have Either Bradycardia or Hypotension

Number of participants observed with Bradycardia or Hypotension who required intervention

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

Population: Number of patients who had Bradycardia or hypotension

ArmMeasureValue (NUMBER)
DexmedetomidineNumber of Participants That Have Either Bradycardia or Hypotension4 participants
PropofolNumber of Participants That Have Either Bradycardia or Hypotension5 participants
Secondary

Post Anesthesia Care Unit (PACU) Length of Stay

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

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

ArmMeasureValue (MEAN)Dispersion
DexmedetomidinePost Anesthesia Care Unit (PACU) Length of Stay159 MinutesStandard Deviation 12
PropofolPost Anesthesia Care Unit (PACU) Length of Stay126 MinutesStandard Deviation 12
Secondary

Total Narcotic Used by Each Participant

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

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

ArmMeasureValue (MEAN)Dispersion
DexmedetomidineTotal Narcotic Used by Each Participant7.1 MicrogramStandard Deviation 23.9
PropofolTotal Narcotic Used by Each Participant9 MicrogramStandard Deviation 24.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026