Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

Study Overview
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Brief Summary
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Operative shoulder arthroscopy under regional block anesthesia often presents with hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure is required to minimize the bleeding. Regional anesthesia is successfully performed to many patients in whom tracheal intubation or the placement of a laryngeal tube is undesired. Propofol has traditionally been used to provide sedation in patients undergoing shoulder arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on blood pressure, the investigators set out to compare intraoperative hemodynamics of both drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators also assessed whether the type of anesthetic agent used for sedation accounted for other differences in intra and post-operative outcome measures.

Official Title
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Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy: a Randomized Controlled Double Blind Trial

Conditions
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Hemodynamic, Sedation, Satisfaction, Personal

Intervention / Treatment
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* Procedure: Shoulder Arthroscopy
* Procedure: Regional Block
* Drug: Propofol
* Drug: Dexmedetomidine
* Diagnostic Test: BIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists score (ASA) I or II. Elective Shoulder arthroscopy. Exclusion Criteria: Allergies to any of the used medications. ASA score of III or above. Cardiac abnormalities. Contraindications to regional blocks. Patient refusal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised controlled double blind trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four. | Procedure: Shoulder Arthroscopy<br>* patients in both groups are programmed for an elective shoulder arthroscopy surgery<br>* Other names: Surgery;Procedure: Regional Block<br>* patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.<br>* Other names: Interscalene brachial plexus block;Drug: Propofol<br>* propofol 10mg/ml was used for sedation as described in the arms section<br>* Other names: Propofol-Lipuro;Diagnostic Test: BIS<br>* sedation level was monitored using bispectral index to achieve values described in the arms group<br>* Other names: Bispectral index;|
| Active Comparator: Dexmedetomidine<br>Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum. | Procedure: Shoulder Arthroscopy<br>* patients in both groups are programmed for an elective shoulder arthroscopy surgery<br>* Other names: Surgery;Procedure: Regional Block<br>* patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.<br>* Other names: Interscalene brachial plexus block;Drug: Dexmedetomidine<br>* Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section<br>* Other names: Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj;Diagnostic Test: BIS<br>* sedation level was monitored using bispectral index to achieve values described in the arms group<br>* Other names: Bispectral index;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iSBP | initial Systolic Blood Pressure (iSBP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room. | Hour 0 | 
| iMAP | initial Mean Arterial blood Pressure (iMAP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room. | Hour 0 | 
| SBP | Change in Systolic Blood Pressure from iSBP | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | 
| MAP | change in Mean Arterial blood Pressure from iMAP | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | 
| Surgeon Satisfaction: Global satisfaction scale | Global satisfaction of the surgeon regarding anesthesia and patient immobility on a scale from 0 (not satisfied) to 10 (completely satisfied) collected at the end of surgery | up to 1 hour after surgery completion | 
| Estimation of Bleeding | Surgeon's evaluation of the bleeding that had affected the surgeon's visibility on a scale from 0 (no bleeding) to 5 (very intense bleeding) collected at the end of surgery | up to 1 hour after surgery completion | 
| Occurence of Hypotension | number of episodes of hypotension ( a drop of systolic blood pressure >30% of the initial value recorded at patient arrival to the operating theatre) | up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR | respiratory rate (RR) per minute | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | 
| BPM | Beats per minute (BPM) | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | 
| SaO2 | Oxygen Saturation (SaO2) (%) | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | 
| Vasopressors OR | use of vasoactive drugs during surgery (Yes or No) | up to 0 minutes after admission to the PACU | 
| Vasopressors PACU | use of vasoactive drugs during PACU stay (Yes or No) | up to 3 hours after surgery completion | 
| tBIS | time to achieve desired Bispectral Index (tBIS) level (minutes) | up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | 
| PS1: scale | Patient Satisfaction 1(PS1): I would want to have the same anesthetic again on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree. | up to 3 hours after surgery completion | 
| PS2: scale | Patient Satisfaction 2(PS2): I felt pain on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree. | up to 3 hours after surgery completion | 
| PS3: scale | Patient Satisfaction 3(PS3): I was satisfied with my anesthetic care on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree. | up to 3 hours after surgery completion | 
| PS4: scale | Patient Satisfaction 4(PS4): I felt relaxed during the procedure on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree. | up to 3 hours after surgery completion | 
| PON | Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No) | up to 3 hours after surgery completion | 
| POV | Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No) | up to 3 hours after surgery completion | 
| Need for rescue analgesia: RA | need for rescue analgesia (RA) opioids at PACU (Yes or No) | up to 3 hours after surgery completion | 
| ALDRETE score | time to reach modified Aldrete score of 9/10 at PACU (minutes) | up to 3 hours after surgery completion | 
| VASi | Visual Analog Scale initial (VASi): Visual analog rating scale for pain (VAS) in which 0 is defined as no pain and 10 as maximum pain at PACU arrival (0-10) | up to 10 minutes after admission to the PACU | 
| VASd | Visual Analog Scale discharge (VASd): Visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain at PACU discharge (0-10) | up to 3 hours after surgery completion | 
| Occurence of Bradycardia | number of episodes of bradycardia (Heart rate <45/min) | up to 0 minutes after admission to the PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Dexmedetomidine, Regional anesthesia, Satisfaction, Shoulder arthroscopy