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

Phase 4

Completed

Conditions: Shoulder Pain

Interventions: Drug: Dexmedetomidine
Drug: Propofol
Other: Interscalene block

Registration Number: NCT02469961

Lead Sponsor: Maimonides Medical Center

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

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Interscalene block	Participants will receive an interscalene block and be sedated with dexmedetomidine
Propofol	Interscalene block	Participants will receive an interscalene block and be sedated with propofol
dexmedetomidine	Dexmedetomidine	Participants will receive an interscalene block and be sedated with dexmedetomidine
Propofol	Propofol	Participants will receive an interscalene block and be sedated with propofol

Primary Outcome Measures

Name	Time	Method
Number of Participants That Need an Airway Intervention.	Participants will be followed from the start of sedation until discharge: approximately 3-5 hr	airway manipulation or repositioning: apnea, oral airway, adjust head

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Have Either Bradycardia or Hypotension	Participants will be followed from the start of sedation until discharge: approximately 3-5 hr	Number of participants observed with Bradycardia or Hypotension who required intervention
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	length of stay in minutes in the Post Anesthesia Care Unit before discharge
Total Narcotic Used by Each Participant	Participants will be followed from the start of sedation until discharge: approximately 3-5 hr	the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents