Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy

NCT ID: NCT04634656

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2021-11-10

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.

Conditions

Cognitive Dysfunction, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Xylocaine

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Seham Mohamed Moeen Ibrahim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seham M Moeen, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Seham Mohamed Moeen

Asyut, Asyut Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Seham M Moeen, MD

Role: CONTACT

seham.moeen@yahoo.com

01006386324 ext. 02

Facility Contacts

Seham M Moeen, MD

Role: primary

seham.moeen@yahoo.com

01006386324 ext. 02

Other Identifiers

SM 2020

Identifier Type: -

Identifier Source: org_study_id