Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

Phase 4

Completed

• Conditions: Hemodynamic; Sedation; Satisfaction, Personal
• Interventions: Procedure: Shoulder Arthroscopy; Procedure: Regional Block; Drug: Dexmedetomidine; Drug: Propofol; Diagnostic Test: BIS

• Registration Number: NCT03775876
• Lead Sponsor: Saint-Joseph University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-09-15
• Study First Submitted: 2018-11-18
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-11
• Last Update Submitted: 2018-12-13
• Study First Posted: 2018-12-14
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Shoulder Arthroscopy	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.
Dexmedetomidine	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.
Dexmedetomidine	Regional Block	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.
Propofol	BIS	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.
Propofol	Shoulder Arthroscopy	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.
Propofol	Regional Block	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.
Dexmedetomidine	BIS	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.
Propofol	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.

Primary Outcome Measures

Name	Time	Method
SBP	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
MAP	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
Surgeon Satisfaction: Global satisfaction scale	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
Estimation of Bleeding	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
Occurence of Hypotension	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)
iSBP	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.
iMAP	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.

Secondary Outcome Measures

Name	Time	Method
RR	at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion	respiratory rate (RR) per minute
PS2: scale	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.
PS3: scale	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.
PS4: scale	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.
PON	up to 3 hours after surgery completion	Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)
POV	up to 3 hours after surgery completion	Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No)
Need for rescue analgesia: RA	up to 3 hours after surgery completion	need for rescue analgesia (RA) opioids at PACU (Yes or No)
BPM	at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion	Beats per minute (BPM)
SaO2	at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion	Oxygen Saturation (SaO2) (%)
Vasopressors OR	up to 0 minutes after admission to the PACU	use of vasoactive drugs during surgery (Yes or No)
Vasopressors PACU	up to 3 hours after surgery completion	use of vasoactive drugs during PACU stay (Yes or No)
tBIS	up to 0 minutes after the end of Propofol or Dexmedetomidine infusion	time to achieve desired Bispectral Index (tBIS) level (minutes)
PS1: scale	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.
ALDRETE score	up to 3 hours after surgery completion	time to reach modified Aldrete score of 9/10 at PACU (minutes)
VASi	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)
VASd	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)
Occurence of Bradycardia	up to 0 minutes after admission to the PACU	number of episodes of bradycardia (Heart rate \<45/min)

Trial Locations

Locations (1)

Hotel Dieu de France Hospital; 🇱🇧 Beirut, Lebanon