Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

NCT03775876 | Completed Phase 4

• 1 other identifier: CEHDF 945
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic; Sedation; Satisfaction, Personal

Keywords

Propofol; Dexmedetomidine; Regional anesthesia; Satisfaction; Shoulder arthroscopy

Outcome Measures

Primary Outcomes (7)

• 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.

  Hour 0

• 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.

  Hour 0

• SBP

  Change in Systolic Blood Pressure from iSBP

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

• MAP

  change in Mean Arterial blood Pressure from iMAP

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

• 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

  up to 1 hour after surgery completion

• 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

  up to 1 hour after surgery completion

• 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)

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

Secondary Outcomes (17)

• RR

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

• BPM

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

• SaO2

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

• Vasopressors OR

  up to 0 minutes after admission to the PACU

• Vasopressors PACU

  up to 3 hours after surgery completion

Other Outcomes (4)

• BIS level

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

• Ramsay sedation scale

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

• Sedation Duration

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

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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; Procedure: Regional Block; Drug: Propofol; Diagnostic Test: BIS

Dexmedetomidine

ACTIVE COMPARATOR

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; Procedure: Regional Block; Drug: Dexmedetomidine; Diagnostic Test: BIS

Interventions

Shoulder Arthroscopy PROCEDURE

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

Also known as: Surgery

Dexmedetomidine; Propofol

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.

Also known as: Interscalene brachial plexus block

Dexmedetomidine; Propofol

Propofol DRUG

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

Also known as: Propofol-Lipuro

Propofol

Dexmedetomidine DRUG

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

Also known as: Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj

Dexmedetomidine

BIS DIAGNOSTIC_TEST

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

Also known as: Bispectral index

Dexmedetomidine; Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

Location

Related Publications (3)

• 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.

  PMID: 25197298 BACKGROUND

• 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.

  PMID: 25834336 BACKGROUND

• 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.

  PMID: 25970229 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Surgical Procedures, Operative; Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hicham A ABOU ZEID, M.D., M.Sc.

  Saint Joseph University School of Medicine

  STUDY CHAIR

• Nouhad S AYOUB, M.D.

  Saint Joseph University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: surgeons, patients as well as the outcome assessor were blinded in regards of the drug used for sedation during surgery (Propofol vs dexmedetomidine)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomised controlled double blind trial

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: December 14, 2018
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: September 15, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)