NCT03775876

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodynamic
• Sedation
• Satisfaction, Personal

Interventions

Type	Name	Description
PROCEDURE	Shoulder Arthroscopy	patients in both groups are programmed for an elective shoulder arthroscopy 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.
DRUG	Propofol	propofol 10mg/ml was used for sedation as described in the arms section
DRUG	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

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-03-01
• Completion: 2018-09-15
• First posted: 2018-12-14
• Last updated: 2018-12-17

Locations

1 site across 1 country: Lebanon