Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy

NCT04634656 | Unknown Phase 2

• 1 other identifier: SM 2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction, Postoperative

Outcome Measures

Primary Outcomes (1)

• Postoperative cognitive function

  Assessed using Mini-Mental State Examination (MMSE) test

  3 days after surgery

Study Arms (2)

Group L

ACTIVE COMPARATOR

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

Group C

PLACEBO COMPARATOR

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

Interventions

Lidocaine 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

Also known as: Xylocaine

Group L

Normal saline 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

Group C

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective arthroscopic shoulder surgery under general anesthesia in beach chair position (BCP),
• Age 20 to 65 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Seham Mohamed Moeen

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Seham M Moeen, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seham M Moeen, MD

CONTACT

01006386324; seham.moeen@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: January 7, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

EG (1)