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Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

NCT03775876 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-12-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Hicham A ABOU ZEID, M.D., M.Sc. · Saint Joseph University School of Medicine

  • Nouhad S AYOUB, M.D. · Saint Joseph University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-03-01
Completion
2018-09-15

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775876 on ClinicalTrials.gov