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

NCT07497009 | Completed DMC

• 1 other identifier: Ms.66.12.2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurocognitive Function of Elderly Patients

Keywords

neurocognitive function; POCD; Dexmedetomidine; lidocaine

Outcome Measures

Primary Outcomes (2)

• 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 ) .

  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.

  change from baseline at 12 weeks

Study Arms (3)

group LIDO

ACTIVE COMPARATOR

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.

Drug: lidocaine

group DEX

EXPERIMENTAL

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

Drug: Dexmedetomidine

group CONTROL

PLACEBO COMPARATOR

normal saline 0.9 %

Drug: normal saline

Interventions

Dexmedetomidine DRUG

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.

Also known as: precedex

group DEX

lidocaine DRUG

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.

Also known as: xylocaine

group LIDO

normal saline DRUG

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.

Also known as: 0.9% sodium chloride

group CONTROL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Lidocaine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident anesthesiologist

Model Details: patiants will randomly assigned into 3 groups : lidocaine group , dexmedetomidene group , control group ( receive normal saline).

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: December 23, 2024
• Primary Completion: April 23, 2025
• Study Completion: August 23, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

EG (1)