Effect of Lidocaine Infusion Versus Dexmedemidine Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography(ERCP).

Benha University

Status: Completed

Conditions: Neurocognitive Function of Elderly Patients

Treatments: Drug: lidocaine; Drug: Dexmedetomidine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07497009

Ms.66.12.2024

Details and patient eligibility

About

dexmedetomidine infusion or lidocaine infusion starting before induction of intravenous general anesthesia and continue as infusion intraoperative can reduce postoperative cognitive dysfunction incidence (primary outcome), postoperative cognitive dilirium, postoperative pain, opioid consumption, postoperative inflammatory response and postoperative adverse events (secondary outcomes) in elderly patients undergoing ERCP.

Full description

Randomization will be achieved using a computer-generated random sequence, and group allocation will be concealed using opaque, sealed envelopes. Both patients and study staff, including those administering the interventions and assessing outcomes will be blinded to the group assignments. The tested syringes will be prepared by the responsible nurse in equal volumes of 50 ml. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only.

The prefilled 50 mL syringes will contain either dexmedetomidine 4 µg/mL or lidocaine 10 mg/mL or NaCl 0.9%. Ten minutes before anesthesia induction all patients will receive an IV infusion at a rate of 0.9mL/kg/h for 10 minutes. This rate corresponds to 0.6 µg/kg dexmedetomidine or 1.5 mg/kg lidocaine. Afterwards, all patients will receive an infusion at a rate of 0.15mL/kg/h until the end of procedure; this rate corresponds to 1.5 mg/kg/h of lidocaine or 0.6 µg/kg/h of dexmedetomidine.

Enrollment: 30 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: The study will include all patients aged 65 years or older of both sex with an ASA I -II - III (as controlled HTN, controlled DM), (MMSE>24) who scheduled for elective ERCP under total intravenous general anesthesia.

Exclusion Criteria :will involve patients lacking informed consents, with severe cardiovascular, respiratory, central nervous system, or kidney dysfunction, communication or assessment impairments, and suspected severe neurocognitive impairment (MMSE score <24). patients with anticipated airway difficulties, alcohol or drug dependence, current sedative, antidepressant, or corticosteroid use, allergy to dexmedetomidine, lidocaine or other used anesthetics, baseline heart rate less than 50 beats per minute due to bradycardia, sick sinus syndrome, or second-degree or higher atrioventricular block without a pacemaker.

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

group LIDO

Active Comparator group

Description:

Similar to other local anesthetics, lidocaine acts at sodium ion channels on the internal surface of nerve cell membranes. The uncharged form of lidocaine diffuses through neural sheaths into the axoplasm before ionizing by combining with hydrogen ions. The resulting cation binds reversibly to sodium channels from the inside, locking them in the open state and preventing nerve depolarization.

Treatment:

Drug: lidocaine

group DEX

Experimental group

Description:

The sedative and analgesic effects induced by an α2-adrenergic receptor agonist (medetomidine) were initially used for veterinary anesthesia.

Treatment:

Drug: Dexmedetomidine

group CONTROL

Placebo Comparator group

Description:

normal saline 0.9 %

Treatment:

Drug: normal saline