Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy

Neuroprotective Effects of Lidocaine on Early Postoperative Cognitive Dysfunction in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position: a Randomized Trial

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

Study Overview

• Status: Unknown
• Conditions: Cognitive Dysfunction, Postoperative
• Intervention / Treatment: Drug: Lidocaine; Drug: Normal saline

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Asyut
    • Assiut, Asyut, Egypt, 71515
      • Recruiting
      • Seham Mohamed Moeen
      • Contact: Seham M Moeen, MD; Phone Number: 02 01006386324; Email: seham.moeen@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative cognitive function	Assessed using Mini-Mental State Examination (MMSE) test	3 days after surgery

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Anticipated): November 10, 2021
• Study Completion (Anticipated): November 10, 2021

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: SM 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No