Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

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: Completed
• Conditions: Sedation; Satisfaction, Personal; Hemodynamic
• Intervention / Treatment: Procedure: Shoulder Arthroscopy; Procedure: Regional Block; Drug: Propofol; Diagnostic test: BIS; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
RR	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	Beats per minute (BPM)	at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
SaO2	Oxygen Saturation (SaO2) (%)	at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Vasopressors OR	use of vasoactive drugs during surgery (Yes or No)	up to 0 minutes after admission to the PACU
Vasopressors PACU	use of vasoactive drugs during PACU stay (Yes or No)	up to 3 hours after surgery completion
tBIS	time to achieve desired Bispectral Index (tBIS) level (minutes)	up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
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.	up to 3 hours after surgery completion
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.	up to 3 hours after surgery completion
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.	up to 3 hours after surgery completion
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.	up to 3 hours after surgery completion
PON	Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)	up to 3 hours after surgery completion
POV	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	need for rescue analgesia (RA) opioids at PACU (Yes or No)	up to 3 hours after surgery completion
ALDRETE score	time to reach modified Aldrete score of 9/10 at PACU (minutes)	up to 3 hours after surgery completion
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)	up to 10 minutes after admission to the PACU
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)	up to 3 hours after surgery completion
Occurence of Bradycardia	number of episodes of bradycardia (Heart rate <45/min)	up to 0 minutes after admission to the PACU

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS level	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	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	total duration of Propofol or Dexmedetomidine infusion in minutes	up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Sedation Dose	total dose of Propofol (mg) or Dexmedetomidine (mcg) used	up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: 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

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): September 15, 2018

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (ACTUAL): December 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Satisfaction; Propofol; Dexmedetomidine; Regional anesthesia; Shoulder arthroscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID 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