Hotel Dieu de France Hospital
Beirut, 166830, Lebanon
NCT Number: NCT03775876
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Beirut, 166830, Lebanon
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients in both groups are programmed for an elective shoulder arthroscopy surgery
Other names: Surgery
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 names: Interscalene brachial plexus block
propofol 10mg/ml was used for sedation as described in the arms section
Other names: Propofol-Lipuro
Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section
Other names: Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj
sedation level was monitored using bispectral index to achieve values described in the arms group
Other names: Bispectral index
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.
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.
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
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
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
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
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)
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
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)
Time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Oxygen Saturation (SaO2) (%)
Time frame: up to 0 minutes after admission to the PACU
use of vasoactive drugs during surgery (Yes or No)
Time frame: up to 3 hours after surgery completion
use of vasoactive drugs during PACU stay (Yes or No)
Time frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
time to achieve desired Bispectral Index (tBIS) level (minutes)
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.
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.
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.
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.
Time frame: up to 3 hours after surgery completion
Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)
Time frame: up to 3 hours after surgery completion
Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No)
Time frame: up to 3 hours after surgery completion
need for rescue analgesia (RA) opioids at PACU (Yes or No)
Time frame: up to 3 hours after surgery completion
time to reach modified Aldrete score of 9/10 at PACU (minutes)
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)
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)
Time frame: up to 0 minutes after admission to the PACU
number of episodes of bradycardia (Heart rate <45/min)
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.
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.
Time frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
total duration of Propofol or Dexmedetomidine infusion in minutes
Time frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
total dose of Propofol (mg) or Dexmedetomidine (mcg) used
Saint-Joseph University
Other
Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy: a Randomized Controlled Double Blind Trial
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