NCT07497009

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neurocognitive Function of Elderly Patients

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	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.
DRUG	lidocaine	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.
DRUG	normal saline	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.

Timeline

• Start date: 2024-12-23
• Primary completion: 2025-04-23
• Completion: 2025-08-23
• First posted: 2026-03-27
• Last updated: 2026-03-31

Locations

1 site across 1 country: Egypt