Phase 4
Completed N=50
Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block
Source: ClinicalTrials.gov NCT02469961 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants That Need an Airway Intervention. — 0; 5 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Need an Airway Intervention. |
0; 5 | — |
| SECONDARY Post Anesthesia Care Unit (PACU) Length of Stay |
159; 126 | — |
| SECONDARY Number of Participants That Have Either Bradycardia or Hypotension |
4; 5 | — |
| SECONDARY Total Narcotic Used by Each Participant |
7.1; 9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02469961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.