Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

Saint-Joseph University

Status and phase: Completed; Phase 4

Conditions: Satisfaction, Personal; Sedation; Hemodynamic

Treatments: Procedure: Regional Block; Drug: Propofol; Drug: Dexmedetomidine; Diagnostic Test: BIS; Procedure: Shoulder Arthroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03775876

CEHDF 945

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Propofol

Active Comparator group

Description:

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.

Treatment:

Procedure: Shoulder Arthroscopy

Diagnostic Test: BIS

Drug: Propofol

Procedure: Regional Block

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Procedure: Shoulder Arthroscopy

Diagnostic Test: BIS

Drug: Dexmedetomidine

Procedure: Regional Block