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

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ClinicalTrials.gov Identifier: NCT02469961
Recruitment Status : Completed
First Posted : June 12, 2015
Results First Posted : February 1, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Piyush Gupta, MD, Maimonides Medical Center

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


Condition or disease Intervention/treatment Phase
Shoulder Pain Drug: Dexmedetomidine Drug: Propofol Other: Interscalene block Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Dexmedetomidine vs Propofol TIVA and Interscalene Block for Shoulder Surgeries in a Beach Chair Sitting Position
Study Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine
Participants will receive an interscalene block and be sedated with dexmedetomidine
Drug: Dexmedetomidine
Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Other Name: precedex

Other: Interscalene block
Interscalene block is used for the main anesthetic for the case

Active Comparator: Propofol
Participants will receive an interscalene block and be sedated with propofol
Drug: Propofol
Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine
Other Name: diprivan

Other: Interscalene block
Interscalene block is used for the main anesthetic for the case




Primary Outcome Measures :
  1. Number of Participants That Need an Airway Intervention. [ Time Frame: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr ]
    airway manipulation or repositioning: apnea, oral airway, adjust head


Secondary Outcome Measures :
  1. Post Anesthesia Care Unit (PACU) Length of Stay [ 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 ]
    length of stay in minutes in the Post Anesthesia Care Unit before discharge

  2. Number of Participants That Have Either Bradycardia or Hypotension [ Time Frame: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr ]
    Number of participants observed with Bradycardia or Hypotension who required intervention

  3. Total Narcotic Used by Each Participant [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469961


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
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Principal Investigator: piyush Gupta, MD Maimonides Medical Center

Publications of Results:
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Responsible Party: Piyush Gupta, MD, Clinical Director, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02469961    
Other Study ID Numbers: 10/07/VA07
First Posted: June 12, 2015    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: April 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action