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

NCT02469961 | Completed Phase 4 Results

• 1 other identifier: 10/07/VA07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Need an Airway Intervention.

  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 Outcomes (3)

• Post Anesthesia Care Unit (PACU) Length of Stay

  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

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

• Total Narcotic Used by Each Participant

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

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

Participants will receive an interscalene block and be sedated with dexmedetomidine

Drug: Dexmedetomidine; Other: Interscalene block

Propofol

ACTIVE COMPARATOR

Participants will receive an interscalene block and be sedated with propofol

Drug: Propofol; Other: Interscalene block

Interventions

Dexmedetomidine DRUG

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

Also known as: precedex

dexmedetomidine

Propofol DRUG

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

Also known as: diprivan

Propofol

Interscalene block OTHER

Interscalene block is used for the main anesthetic for the case

Propofol; dexmedetomidine

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (2)

• Mehta PP, Kochhar G, Kalra S, Maurer W, Tetzlaff J, Singh G, Lopez R, Sanaka MR, Vargo JJ. Can a validated sleep apnea scoring system predict cardiopulmonary events using propofol sedation for routine EGD or colonoscopy? A prospective cohort study. Gastrointest Endosc. 2014 Mar;79(3):436-44. doi: 10.1016/j.gie.2013.09.022. Epub 2013 Nov 9.

  PMID: 24219821 RESULT

• Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31.

  PMID: 11056756 RESULT

MeSH Terms

Conditions

Shoulder Pain

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

There was no limitations

Results Point of Contact

• Title: Piyush Gupta, Director of clinical affairs
• Organization: Maimonides Medical Center

pgupta@maimonidesmed.org

718-283-7189

Study Officials

• piyush Gupta, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 12, 2015
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: July 1, 2012
• Last Updated: November 13, 2024
• Results First Posted: February 1, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)