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Completed

NCT Number: NCT02469961

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

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

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: precedex

Propofol

Drug

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

Other names: diprivan

Interscalene block

Other

Interscalene block is used for the main anesthetic for the case

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Official study title

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

Acronym: TIVA

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 12, 2015
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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