Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

December 13, 2018 updated by: Hicham Abou Zeid, Saint-Joseph University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon, 166830
        • Hotel Dieu de France Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Propofol
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
patients in both groups are programmed for an elective shoulder arthroscopy surgery
Other Names:
  • Surgery
Procedure: Regional 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.
Other Names:
  • Interscalene brachial plexus block
Drug: Propofol
propofol 10mg/ml was used for sedation as described in the arms section
Other Names:
  • Propofol-Lipuro
Diagnostic test: BIS
sedation level was monitored using bispectral index to achieve values described in the arms group
Other Names:
  • Bispectral index
ACTIVE_COMPARATOR: Dexmedetomidine
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
patients in both groups are programmed for an elective shoulder arthroscopy surgery
Other Names:
  • Surgery
Procedure: Regional 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.
Other Names:
  • Interscalene brachial plexus block
Diagnostic test: BIS
sedation level was monitored using bispectral index to achieve values described in the arms group
Other Names:
  • Bispectral index
Drug: Dexmedetomidine
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Hour 0
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.
Hour 0
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
at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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
at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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
up to 1 hour after surgery completion
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
up to 1 hour after surgery completion
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)
up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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)
at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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) (%)
at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Vasopressors OR
Time Frame: up to 0 minutes after admission to the PACU
use of vasoactive drugs during surgery (Yes or No)
up to 0 minutes after admission to the PACU
Vasopressors PACU
Time Frame: up to 3 hours after surgery completion
use of vasoactive drugs during PACU stay (Yes or No)
up to 3 hours after surgery completion
tBIS
Time Frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
time to achieve desired Bispectral Index (tBIS) level (minutes)
up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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.
up to 3 hours after surgery completion
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.
up to 3 hours after surgery completion
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.
up to 3 hours after surgery completion
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.
up to 3 hours after surgery completion
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)
up to 3 hours after surgery completion
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)
up to 3 hours after surgery completion
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)
up to 3 hours after surgery completion
ALDRETE score
Time Frame: up to 3 hours after surgery completion
time to reach modified Aldrete score of 9/10 at PACU (minutes)
up to 3 hours after surgery completion
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)
up to 10 minutes after admission to the PACU
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)
up to 3 hours after surgery completion
Occurence of Bradycardia
Time Frame: up to 0 minutes after admission to the PACU
number of episodes of bradycardia (Heart rate <45/min)
up to 0 minutes after admission to the PACU

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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.
at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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
up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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
up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saint-Joseph University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hicham A ABOU ZEID, M.D., M.Sc., Saint Joseph University School of Medicine
  • Principal Investigator: Nouhad S AYOUB, M.D., Saint Joseph University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEHDF 945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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