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

October 22, 2024 updated by: Piyush Gupta, MD, Maimonides Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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
Other: Interscalene block
Interscalene block is used for the main anesthetic for the case
Drug: Propofol
Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine
Other Names:
  • diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed from the start of sedation until discharge: approximately 3-5 hr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation
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
Participants will be followed from the start of sedation until discharge: approximately 3-5 hr
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
Participants will be followed from the start of sedation until discharge: approximately 3-5 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimonides Medical Center

Investigators

  • Principal Investigator: piyush Gupta, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimated)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

November 13, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/07/VA07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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