Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04634656
Collaborator
(none)
80
1
2
10.1
7.9

Study Details

Study Description

Brief Summary

The beach chair position (BCP) combined with deliberate hypotension impair cerebral perfusion pressure and oxygenation during arthroscopic shoulder surgeries and produce cerebral ischemia.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Arthroscopic diagnosis and treatment of shoulder disorders have replaced open procedure as the primary treatment method. The beach chair (BCP) and lateral decubitus (LDP) positions are both considered as reliable techniques for performing effective arthroscopic shoulder surgeries. The usage of BCP for shoulder arthroscopic operations started from early 1980s.

The advantages of BCP include lack of brachial plexus strain, good intra-articular visualization, with the ease of conversion to an open approach if required.

The BCP combined with deliberate hypotension has been used to decrease intraoperative blood loss and allow a relatively blood-free surgical field. However, this combination has the risk to impair cerebral perfusion pressure and oxygenation during surgery and produce cerebral ischemia.

Lidocaine, a commonly used local anesthetic and class IB antiarrhythmic drug, that readily crosses the blood - brain barrier. Evans et al. initially reported cerebral protection of lidocaine in a feline model of cerebral arterial gas embolism. Later on, the effects of lidocaine on perioperative neuroprotection were detected. However, the mechanisms underlying lidocaine treatment-induced neuroprotection remain incompletely understood.

Lidocaine may provide cerebral protection through many mechanisms, including decreasing the cerebral metabolic rate, decelerating the ischemic transmembrane ion shift, and reducing the ischemic excitotoxin release.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Neuroprotective Effects of Lidocaine on Early Postoperative Cognitive Dysfunction in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position: a Randomized Trial
Actual Study Start Date :
Jan 7, 2021
Anticipated Primary Completion Date :
Nov 10, 2021
Anticipated Study Completion Date :
Nov 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group L

Patients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery.

Drug: Lidocaine
Patients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery
Other Names:
  • Xylocaine
  • Placebo Comparator: Group C

    Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery.

    Drug: Normal saline
    Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative cognitive function [3 days after surgery]

      Assessed using Mini-Mental State Examination (MMSE) test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing elective arthroscopic shoulder surgery under general anesthesia in beach chair position (BCP),

    • Age 20 to 65 years old.

    Exclusion Criteria:
    • Mini-Mental State Examination (MMSE) score < 23 before surgery

    • History of neurological disease (such as previous episodes of cerebral ischemia or stroke).

    • History of psychological disorder

    • Suspected history of adverse reactions to lidocaine

    • Drug or alcohol abuse

    • History of diabetes mellitus, sever hypertension, severe anemia, hepatic or renal dysfunction

    • Unwillingness to comply with protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seham Mohamed Moeen Assiut Asyut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Seham M Moeen, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seham Mohamed Moeen Ibrahim, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04634656
    Other Study ID Numbers:
    • SM 2020
    First Posted:
    Nov 18, 2020
    Last Update Posted:
    Jan 8, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 8, 2021