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Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

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ClinicalTrials.gov Identifier: NCT03775876
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hicham Abou Zeid, Saint-Joseph University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemodynamic Sedation Satisfaction, Personal Procedure: Shoulder Arthroscopy Procedure: Regional Block Drug: Propofol Drug: Dexmedetomidine Diagnostic Test: BIS Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised controlled double blind trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: surgeons, patients as well as the outcome assessor were blinded in regards of the drug used for sedation during surgery (Propofol vs dexmedetomidine)
Primary Purpose: Supportive Care
Official Title: Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy: a Randomized Controlled Double Blind Trial
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propofol
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
patients in both groups are programmed for an elective shoulder arthroscopy surgery
Other Name: Surgery

Procedure: Regional Block
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.
Other Name: Interscalene brachial plexus block

Drug: Propofol
propofol 10mg/ml was used for sedation as described in the arms section
Other Name: Propofol-Lipuro

Diagnostic Test: BIS
sedation level was monitored using bispectral index to achieve values described in the arms group
Other Name: Bispectral index

Active Comparator: Dexmedetomidine
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
patients in both groups are programmed for an elective shoulder arthroscopy surgery
Other Name: Surgery

Procedure: Regional Block
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.
Other Name: Interscalene brachial plexus block

Drug: Dexmedetomidine
Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section
Other Name: Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj

Diagnostic Test: BIS
sedation level was monitored using bispectral index to achieve values described in the arms group
Other Name: Bispectral index




Primary Outcome Measures :
  1. iSBP [ Time Frame: Hour 0 ]
    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.

  2. iMAP [ Time Frame: Hour 0 ]
    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.

  3. SBP [ Time Frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    Change in Systolic Blood Pressure from iSBP

  4. MAP [ Time Frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    change in Mean Arterial blood Pressure from iMAP

  5. Surgeon Satisfaction: Global satisfaction scale [ Time Frame: up to 1 hour after surgery completion ]
    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

  6. Estimation of Bleeding [ Time Frame: up to 1 hour after surgery completion ]
    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

  7. Occurence of Hypotension [ Time Frame: up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU) ]
    number of episodes of hypotension ( a drop of systolic blood pressure >30% of the initial value recorded at patient arrival to the operating theatre)


Secondary Outcome Measures :
  1. RR [ Time Frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    respiratory rate (RR) per minute

  2. BPM [ Time Frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    Beats per minute (BPM)

  3. SaO2 [ Time Frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    Oxygen Saturation (SaO2) (%)

  4. Vasopressors OR [ Time Frame: up to 0 minutes after admission to the PACU ]
    use of vasoactive drugs during surgery (Yes or No)

  5. Vasopressors PACU [ Time Frame: up to 3 hours after surgery completion ]
    use of vasoactive drugs during PACU stay (Yes or No)

  6. tBIS [ Time Frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    time to achieve desired Bispectral Index (tBIS) level (minutes)

  7. PS1: scale [ Time Frame: up to 3 hours after surgery completion ]
    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.

  8. PS2: scale [ Time Frame: up to 3 hours after surgery completion ]
    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.

  9. PS3: scale [ Time Frame: up to 3 hours after surgery completion ]
    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.

  10. PS4: scale [ Time Frame: up to 3 hours after surgery completion ]
    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.

  11. PON [ Time Frame: up to 3 hours after surgery completion ]
    Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)

  12. POV [ Time Frame: up to 3 hours after surgery completion ]
    Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No)

  13. Need for rescue analgesia: RA [ Time Frame: up to 3 hours after surgery completion ]
    need for rescue analgesia (RA) opioids at PACU (Yes or No)

  14. ALDRETE score [ Time Frame: up to 3 hours after surgery completion ]
    time to reach modified Aldrete score of 9/10 at PACU (minutes)

  15. VASi [ Time Frame: up to 10 minutes after admission to the PACU ]
    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)

  16. VASd [ Time Frame: up to 3 hours after surgery completion ]
    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)

  17. Occurence of Bradycardia [ Time Frame: up to 0 minutes after admission to the PACU ]
    number of episodes of bradycardia (Heart rate <45/min)


Other Outcome Measures:
  1. BIS level [ Time Frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    Bispectral index (BIS) level value (0-100). BIS is used to monitor depth of anesthesia or sedation.The BIS is an electroencephalogram-derived multivariant scale.The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (Normal EEG activity or patient completely awake). 0 = EEG silence, [0 to 20] = burst suppression on EEG, [20 to 40] = deep hypnotic state, [40 to 60] = general anesthesia, [60 to 80] = sedation but individual responds to loud commands or mild shaking, [80 to 99] = sedation but individual responds to normal voice and 100 = Completely Awake.

  2. Ramsay sedation scale [ Time Frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    Ramsay sedation scale value (1-6): 1=Anxious, agitated, restless; 2=Cooperative, oriented, tranquil; 3=Responsive to commands only; 4=Brisk response to light glabellar tap or loud auditory stimulus; 5=Sluggish response to light glabellar tap or loud auditory stimulus; 6=No response to light glabellar tap or loud auditory stimulus.

  3. Sedation Duration [ Time Frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    total duration of Propofol or Dexmedetomidine infusion in minutes

  4. Sedation Dose [ Time Frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion ]
    total dose of Propofol (mg) or Dexmedetomidine (mcg) used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775876


Locations
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Lebanon
Hotel Dieu de France Hospital
Beirut, Lebanon, 166830
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Study Chair: Hicham A ABOU ZEID, M.D., M.Sc. Saint Joseph University School of Medicine
Principal Investigator: Nouhad S AYOUB, M.D. Saint Joseph University School of Medicine
Publications:
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Responsible Party: Hicham Abou Zeid, Assistant Professor, Saint-Joseph University
ClinicalTrials.gov Identifier: NCT03775876    
Other Study ID Numbers: CEHDF 945
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hicham Abou Zeid, Saint-Joseph University:
Propofol
Dexmedetomidine
Regional anesthesia
Satisfaction
Shoulder arthroscopy
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action