Clinical trial NCT03775876: Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy
Official title: Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy: a Randomized Controlled Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic
Sedation
Satisfaction, Personal
Keywords: Propofol
Dexmedetomidine
Regional anesthesia
Satisfaction
Shoulder arthroscopy
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled double blind trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: iSBP
timeFrame: Hour 0
measure: iMAP
timeFrame: Hour 0
measure: SBP
timeFrame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: MAP
timeFrame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: Surgeon Satisfaction: Global satisfaction scale
timeFrame: up to 1 hour after surgery completion
measure: Estimation of Bleeding
timeFrame: up to 1 hour after surgery completion
measure: Occurence of Hypotension
timeFrame: up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU)
Secondary outcomes:
measure: RR
timeFrame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: BPM
timeFrame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: SaO2
timeFrame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: Vasopressors OR
timeFrame: up to 0 minutes after admission to the PACU
measure: Vasopressors PACU
timeFrame: up to 3 hours after surgery completion
measure: tBIS
timeFrame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: PS1: scale
timeFrame: up to 3 hours after surgery completion
measure: PS2: scale
timeFrame: up to 3 hours after surgery completion
measure: PS3: scale
timeFrame: up to 3 hours after surgery completion
measure: PS4: scale
timeFrame: up to 3 hours after surgery completion
measure: PON
timeFrame: up to 3 hours after surgery completion
measure: POV
timeFrame: up to 3 hours after surgery completion
measure: Need for rescue analgesia: RA
timeFrame: up to 3 hours after surgery completion
measure: ALDRETE score
timeFrame: up to 3 hours after surgery completion
measure: VASi
timeFrame: up to 10 minutes after admission to the PACU
measure: VASd
timeFrame: up to 3 hours after surgery completion
measure: Occurence of Bradycardia
timeFrame: up to 0 minutes after admission to the PACU
Other outcomes:
measure: BIS level
timeFrame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: Ramsay sedation scale
timeFrame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: Sedation Duration
timeFrame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
measure: Sedation Dose
timeFrame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital
Study officials:
affiliation: Saint Joseph University School of Medicine
name: Hicham A ABOU ZEID, M.D., M.Sc.
role: STUDY_CHAIR
affiliation: Saint Joseph University School of Medicine
name: Nouhad S AYOUB, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.