Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

Saint-Joseph University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Hemodynamic Sedation Satisfaction, Personal

Interventions

Shoulder ArthroscopyPROCEDURE

patients in both groups are programmed for an elective shoulder arthroscopy surgery

Regional BlockPROCEDURE

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.

PropofolDRUG

propofol 10mg/ml was used for sedation as described in the arms section

DexmedetomidineDRUG

Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section

BISDIAGNOSTIC_TEST

sedation level was monitored using bispectral index to achieve values described in the arms group

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hotel Dieu de France Hospital

Beirut, Lebanon

Outcomes

Primary Outcomes

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.

Time frame: Hour 0

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.

Time frame: Hour 0

SBP

Change in Systolic Blood Pressure from iSBP

Time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

MAP

change in Mean Arterial blood Pressure from iMAP

Time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

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

Time frame: up to 1 hour after surgery completion

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

Time frame: up to 1 hour after surgery completion

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)

Time frame: up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU)

Secondary Outcomes

respiratory rate (RR) per minute

Time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

BPM

Beats per minute (BPM)

Time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

SaO2

Oxygen Saturation (SaO2) (%)

Time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion

Vasopressors OR

use of vasoactive drugs during surgery (Yes or No)

Time frame: up to 0 minutes after admission to the PACU

Vasopressors PACU

use of vasoactive drugs during PACU stay (Yes or No)