Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775876
• Other study ID #: CEHDF 945
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: September 15, 2018

Study information

• Verified date: December 2018
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic
• Satisfaction, Personal
• Sedation

Intervention

Procedure:
• Shoulder Arthroscopy
patients in both groups are programmed for an elective shoulder arthroscopy surgery
• 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.

Drug:
• Propofol
propofol 10mg/ml was used for sedation as described in the arms section
• Dexmedetomidine
Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section

Diagnostic Test:
• BIS
sedation level was monitored using bispectral index to achieve values described in the arms group

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Sedation Duration	total duration of Propofol or Dexmedetomidine infusion in minutes	up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Other	Sedation Dose	total dose of Propofol (mg) or Dexmedetomidine (mcg) used	up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	BPM	Beats per minute (BPM)	at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Secondary	SaO2	Oxygen Saturation (SaO2) (%)	at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Secondary	Vasopressors OR	use of vasoactive drugs during surgery (Yes or No)	up to 0 minutes after admission to the PACU
Secondary	Vasopressors PACU	use of vasoactive drugs during PACU stay (Yes or No)	up to 3 hours after surgery completion
Secondary	tBIS	time to achieve desired Bispectral Index (tBIS) level (minutes)	up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	PON	Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)	up to 3 hours after surgery completion
Secondary	POV	Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No)	up to 3 hours after surgery completion
Secondary	Need for rescue analgesia: RA	need for rescue analgesia (RA) opioids at PACU (Yes or No)	up to 3 hours after surgery completion
Secondary	ALDRETE score	time to reach modified Aldrete score of 9/10 at PACU (minutes)	up to 3 hours after surgery completion
Secondary	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
Secondary	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
Secondary	Occurence of Bradycardia	number of episodes of bradycardia (Heart rate <45/min)	up to 0 minutes after admission to the PACU