Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy

• ClinicalTrials.gov Identifier: NCT04634656
• Recruitment Status: Recruiting
• First Posted: November 18, 2020
• Last Update Posted: January 8, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Seham Mohamed Moeen Ibrahim, Assiut University

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
Cognitive Dysfunction, Postoperative	Drug: Lidocaine; Drug: Normal saline	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 (Clinical Trial)
• Estimated 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: January 7, 2021
• Estimated Primary Completion Date: November 10, 2021
• Estimated Study Completion Date: November 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 Name: 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 [ Time Frame: 3 days after surgery ]
   Assessed using Mini-Mental State Examination (MMSE) test

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Seham M Moeen, MD; 01006386324 ext 02; seham.moeen@yahoo.com

Locations

Egypt

Seham Mohamed Moeen; Recruiting

Assiut, Asyut, Egypt, 71515

Contact: Seham M Moeen, MD 01006386324 ext 02 seham.moeen@yahoo.com

Sponsors and Collaborators

Assiut University

Investigators

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

More Information

• Responsible Party: Seham Mohamed Moeen Ibrahim, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04634656
• Other Study ID Numbers: SM 2020
• First Posted: November 18, 2020
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Postoperative Cognitive Complications; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action