Shoulder Pain
Conditions
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
Interventions
Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine
Interscalene block is used for the main anesthetic for the case
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine Participants will receive an interscalene block and be sedated with dexmedetomidine
Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
Interscalene block: Interscalene block is used for the main anesthetic for the case | 21 |
| Propofol Participants will receive an interscalene block and be sedated with propofol
Propofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine
Interscalene block: Interscalene block is used for the main anesthetic for the case | 24 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 4 | 1 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Propofol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 24 Participants | 45 Participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 22 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 24 |
| serious Total, serious adverse events | 0 / 21 | 0 / 24 |
Outcome results
Number of Participants That Need an Airway Intervention.
airway manipulation or repositioning: apnea, oral airway, adjust head
Time frame: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Number of Participants That Need an Airway Intervention. | 0 participants |
| Propofol | Number of Participants That Need an Airway Intervention. | 5 participants |
Number of Participants That Have Either Bradycardia or Hypotension
Number of participants observed with Bradycardia or Hypotension who required intervention
Time frame: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr
Population: Number of patients who had Bradycardia or hypotension
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Number of Participants That Have Either Bradycardia or Hypotension | 4 participants |
| Propofol | Number of Participants That Have Either Bradycardia or Hypotension | 5 participants |
Post Anesthesia Care Unit (PACU) Length of Stay
length of stay in minutes in the Post Anesthesia Care Unit before discharge
Time frame: Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine | Post Anesthesia Care Unit (PACU) Length of Stay | 159 Minutes | Standard Deviation 12 |
| Propofol | Post Anesthesia Care Unit (PACU) Length of Stay | 126 Minutes | Standard Deviation 12 |
Total Narcotic Used by Each Participant
the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents
Time frame: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine | Total Narcotic Used by Each Participant | 7.1 Microgram | Standard Deviation 23.9 |
| Propofol | Total Narcotic Used by Each Participant | 9 Microgram | Standard Deviation 24.2 |