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OpenTrials
Completed

NCT Number: NCT07497009

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

Other names: precedex

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.

Other names: xylocaine

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.

Other names: 0.9% sodium chloride

Primary outcomes

  1. The incidence of POCD

    Time frame: 24-72 hours postoperatively

    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 ) .

  2. the incidence of post operative cognitive dysfunction

    Time frame: change from baseline at 12 weeks

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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.