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Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy

Primary Purpose

Cognitive Dysfunction, Postoperative

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine
Normal saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Dysfunction, Postoperative

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seham Mohamed MoeenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group L

Group C

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Postoperative cognitive function
Assessed using Mini-Mental State Examination (MMSE) test

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
January 7, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04634656
Brief Title
Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy
Official Title
Neuroprotective Effects of Lidocaine on Early Postoperative Cognitive Dysfunction in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
November 10, 2021 (Anticipated)
Study Completion Date
November 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery
Primary Outcome Measure Information:
Title
Postoperative cognitive function
Description
Assessed using Mini-Mental State Examination (MMSE) test
Time Frame
3 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seham Mohamed Moeen
City
Assiut
State/Province
Asyut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@yahoo.com

12. IPD Sharing Statement

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Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy

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