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

Benha University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neurocognitive Function of Elderly Patients

Interventions

DexmedetomidineDRUG

patients will receive 0.6 µg/kg dexmedetomidine bolus 10 min before induction then it will be infused intravenously at a rate of 0.6 μg/Kg/h. until end of surgery.

lidocaineDRUG

patients will be received 1.5 mg/kg lidocaine bolus 10min before induction of anaesthesia, followed by continuous infusion at a rate of 1.5 mg/Kg/h until end of surgery.

normal salineDRUG

patients will receive 0.9% isotonic saline bolus followed by IV infusion at a rate of 0.9 ml/Kg/h till the end of surgery.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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. \-

Outcomes

Primary Outcomes

The incidence of POCD

determined by The mini-mental state examination( range from 0 to 30 , scores \> 25 interpreted as normal cognitive status) score mini-cog score Richmond Agitation Sedation Scale(range from +4 to -5 , score 0 signifies a calm and alert patient ) .

Time frame: 24-72 hours postoperatively

the incidence of post operative cognitive dysfunction

determined by The mini-mental state examination score at post operative day 1 ,post operative day 3 scores \>25 interpreted as normal cognitive status.

Time frame: change from baseline at 12 weeks