Hemodynamic, Sedation, Satisfaction, Personal
Conditions
Keywords
Propofol, Dexmedetomidine, Regional anesthesia, Satisfaction, Shoulder arthroscopy
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.
Interventions
PROCEDUREShoulder Arthroscopy
patients in both groups are programmed for an elective shoulder arthroscopy surgery
PROCEDURERegional 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.
DRUGPropofol
propofol 10mg/ml was used for sedation as described in the arms section
DRUGDexmedetomidine
Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section
DIAGNOSTIC_TESTBIS
sedation level was monitored using bispectral index to achieve values described in the arms group
Sponsors
Saint-Joseph University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, 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)
Intervention model description
randomised controlled double blind trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of Hypotension | 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) |
| MAP | 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 |
| Estimation of Bleeding | 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 |
| Surgeon Satisfaction: Global satisfaction scale | 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 |
| iSBP | 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. |
| iMAP | 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. |
| SBP | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PS1: scale | 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. |
| PS2: scale | 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. |
| PS3: scale | 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. |
| PS4: scale | 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. |
| POV | up to 3 hours after surgery completion | Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No) |
| Need for rescue analgesia: RA | up to 3 hours after surgery completion | need for rescue analgesia (RA) opioids at PACU (Yes or No) |
| ALDRETE score | up to 3 hours after surgery completion | time to reach modified Aldrete score of 9/10 at PACU (minutes) |
| VASi | 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) |
| VASd | 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) |
| Occurence of Bradycardia | up to 0 minutes after admission to the PACU | number of episodes of bradycardia (Heart rate \<45/min) |
| PON | up to 3 hours after surgery completion | Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No) |
| RR | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | respiratory rate (RR) per minute |
| BPM | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | Beats per minute (BPM) |
| SaO2 | at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | Oxygen Saturation (SaO2) (%) |
| Vasopressors OR | up to 0 minutes after admission to the PACU | use of vasoactive drugs during surgery (Yes or No) |
| Vasopressors PACU | up to 3 hours after surgery completion | use of vasoactive drugs during PACU stay (Yes or No) |
| tBIS | up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | time to achieve desired Bispectral Index (tBIS) level (minutes) |
Other
| Measure | Time frame | Description |
|---|---|---|
| BIS level | 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. |
| Sedation Dose | up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | total dose of Propofol (mg) or Dexmedetomidine (mcg) used |
| Sedation Duration | up to 0 minutes after the end of Propofol or Dexmedetomidine infusion | total duration of Propofol or Dexmedetomidine infusion in minutes |
| Ramsay sedation scale | 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. |
Countries
Lebanon
Outcome results
None listed