CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Dexmedetomidine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02469961
NCT02469961Phase 4Completed

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

Maimonides Medical Center·interventional·Posted Jun 12, 2015·Updated Nov 13, 2024

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine, Propofol, and 1 other intervention for Shoulder Pain. Completed, enrolled 50 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShoulder Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 12, 2015
Enrollment StartOct 1, 2010
Primary CompletionAug 1, 2011
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.1 years ago

Interventions

Dexmedetomidinedrug

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

Propofoldrug

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

Interscalene blockother

Interscalene block is used for the main anesthetic for the case