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HemodynamicPhase 4NCT03775876

Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

A Phase 4 study testing Shoulder Arthroscopy, Regional Block and Propofol in people with Hemodynamic and Sedation, run by Saint-Joseph University at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hemodynamic, Sedation, Satisfaction, Personal
What is being tested?
Shoulder Arthroscopy, Regional Block and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteLebanon
Study dates
1 Mar 2017to 15 Sep 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists score (ASA) I or II.
  • Elective Shoulder arthroscopy.

Who cannot join

  • Allergies to any of the used medications.
  • ASA score of III or above.
  • Cardiac abnormalities.
  • Contraindications to regional blocks.
  • Patient refusal.

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

  • Hotel Dieu de France Hospital

    Beirut, 166830

Other trials in Lebanon

About this study

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

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.

Being tested
Shoulder Arthroscopy, Regional Block, Propofol, Dexmedetomidine, BIS
Keywords
Propofol, Dexmedetomidine, Regional anesthesia, Satisfaction, Shoulder arthroscopy
Medical subject headings
Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shoulder ArthroscopyProcedure or surgery

    Also called Surgery

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

  • Regional BlockProcedure or surgery

    Also called Interscalene brachial plexus 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.

  • PropofolDrug

    Also called Propofol-Lipuro

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

  • DexmedetomidineDrug

    Also called Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj

    Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section

  • BISDiagnostic test

    Also called Bispectral index

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

Study groups in NCT03775876
Study groupRoleWhat they receive
PropofolActive comparatorPatients 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.
Receives: Procedure: Shoulder Arthroscopy; Procedure: Regional Block; Drug: Propofol; Diagnostic Test: BIS
DexmedetomidineActive comparatorPatients 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.
Receives: Procedure: Shoulder Arthroscopy; Procedure: Regional Block; Drug: Dexmedetomidine; Diagnostic Test: BIS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Hour 0

  2. 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.

    Measured: Hour 0

  3. SBP

    Change in Systolic Blood Pressure from iSBP

    Measured: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

  4. MAP

    change in Mean Arterial blood Pressure from iMAP

    Measured: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

  5. 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

    Measured: up to 1 hour after surgery completion

  6. 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

    Measured: up to 1 hour after surgery completion

  7. 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)

    Measured: up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU)

Secondary outcomes (17)

  1. RR

    respiratory rate (RR) per minute

    Measured: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

  2. BPM

    Beats per minute (BPM)

    Measured: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

  3. SaO2

    Oxygen Saturation (SaO2) (%)

    Measured: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

  4. Vasopressors OR

    use of vasoactive drugs during surgery (Yes or No)

    Measured: up to 0 minutes after admission to the PACU

  5. Vasopressors PACU

    use of vasoactive drugs during PACU stay (Yes or No)

    Measured: up to 3 hours after surgery completion

  6. tBIS

    time to achieve desired Bispectral Index (tBIS) level (minutes)

    Measured: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

  7. 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.

    Measured: up to 3 hours after surgery completion

  8. 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.

    Measured: up to 3 hours after surgery completion

  9. 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.

    Measured: up to 3 hours after surgery completion

  10. 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.

    Measured: up to 3 hours after surgery completion

  11. PON

    Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)

    Measured: up to 3 hours after surgery completion

  12. POV

    Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No)

    Measured: up to 3 hours after surgery completion

  13. Need for rescue analgesia: RA

    need for rescue analgesia (RA) opioids at PACU (Yes or No)

    Measured: up to 3 hours after surgery completion

  14. ALDRETE score

    time to reach modified Aldrete score of 9/10 at PACU (minutes)

    Measured: up to 3 hours after surgery completion

  15. 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)

    Measured: up to 10 minutes after admission to the PACU

  16. 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)

    Measured: up to 3 hours after surgery completion

  17. Occurence of Bradycardia

    number of episodes of bradycardia (Heart rate <45/min)

    Measured: up to 0 minutes after admission to the PACU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2018
  2. Study start1 Mar 2017
  3. Primary completion1 Mar 2018
  4. Study completion15 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomised controlled double blind trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03775876
Sponsor's protocol ID
CEHDF 945
Status last verified
Dec 2018
First submitted
18 Nov 2018
Last updated
17 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peng K, Li J, Ji FH, Li Z. Dexmedetomidine compared with propofol for pediatric sedation during cerebral angiography. J Res Med Sci. 2014 Jun;19(6):549-54.

    PubMed 25197298

  • Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.

    PubMed 25834336

  • Wu Y, Zhang Y, Hu X, Qian C, Zhou Y, Xie J. A comparison of propofol vs. dexmedetomidine for sedation, haemodynamic control and satisfaction, during esophagogastroduodenoscopy under conscious sedation. J Clin Pharm Ther. 2015 Aug;40(4):419-25. doi: 10.1111/jcpt.12282. Epub 2015 May 13.

    PubMed 25970229

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shoulder Arthroscopy, Regional Block and Propofol in people with Hemodynamic and Sedation, run by Saint-Joseph University at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iSBP (time frame: Hour 0). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03775876, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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