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

Shoulder Pain Clinical Trial

— TIVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469961
• Other study ID #: 10/07/VA07
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2015
• Last updated: February 10, 2016
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: February 2016
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

References & 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. Gastro — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Post Anesthesia Care Unit (PACU) Length of Stay	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	No
Secondary	Number of Participants That Have Either Bradycardia or Hypotension	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	Yes
Secondary	Total Narcotic Used by Each Participant	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	Yes