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

NCT02469961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-13

Study results available
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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

Interventions

DRUG

Dexmedetomidine

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

DRUG

Propofol

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

OTHER

Interscalene block

Interscalene block is used for the main anesthetic for the case

Sponsors & Collaborators

  • Maimonides Medical Center

    lead OTHER

Principal Investigators

  • piyush Gupta, MD · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-08-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469961 on ClinicalTrials.gov