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Completed

NCT Number: NCT03775876

Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shoulder Arthroscopy

Procedure

patients in both groups are programmed for an elective shoulder arthroscopy surgery

Other names: Surgery

Regional Block

Procedure

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

Drug

propofol 10mg/ml was used for sedation as described in the arms section

Other names: Propofol-Lipuro

Dexmedetomidine

Drug

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

BIS

Diagnostic Test

sedation level was monitored using bispectral index to achieve values described in the arms group

Other names: Bispectral index

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2018
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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