Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries

NCT07108764 | Recruiting

• 1 other identifier: 36265MD399/4/25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effect of intraoperative infusion of either lidocaine or dexmedetomidine on the incidence of postoperative delirium (POD) in elderly patients undergoing major surgeries. It also aims to evaluate the impact of both medications on intraoperative regional cerebral oxygen saturation (rSO₂).

Conditions

Intraoperative Infusion; Lidocaine; Dexmedetomidine; Cerebral Oxygen Saturation; Postoperative Delirium; Elderly Patients; Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Incidence of postoperative delirium (POD) will be recorded.

  Three days after surgery

Secondary Outcomes (6)

• Regional cerebral oxygen saturation

  Till end of surgery (Up to 2 hours)

• Degree of pain

  24 hours postoperatively

• Postoperative opioid consumption

  24 hours postoperatively

• Heart rate

  Till end of surgery (Up to 2 hours)

• Mean arterial blood pressure

  Till end of surgery (Up to 2 hours)

Study Arms (2)

Lidocaine group

EXPERIMENTAL

Patients will receive an IV bolus (50 ml) of lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. This will be followed by intraoperative lidocaine infusion in a dose of 1.5mg /kg/hr till the end of surgery.

Drug: Lidocaine

Dexmedetomidine group

EXPERIMENTAL

Patients will receive an IV bolus (50 ml) of dexmedetomidine in dose 0.5 μg/kg over 10 min before induction of anesthesia. This will be followed by intraoperative dexmedetomidine infusion in a dose of 0.3 μg/kg/hr till the end of surgery.

Drug: Dexmedetomidine

Interventions

Lidocaine DRUG

Patients will receive an IV bolus (50 ml) of lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. This will be followed by intraoperative lidocaine infusion in a dose of 1.5mg /kg/hr till the end of surgery.

Lidocaine group

Dexmedetomidine DRUG

Patients will receive an IV bolus (50 ml) of dexmedetomidine in dose 0.5 μg/kg over 10 min before induction of anesthesia. This will be followed by intraoperative dexmedetomidine infusion in a dose of 0.3 μg/kg/hr till the end of surgery.

Dexmedetomidine group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 65years old.
• Both sexes.
• Physical status classification of II - III according to the American Society of Anesthesiologists (ASA).
• Undergo elective non-cardiac surgeries.

You may not qualify if:

• History of mental illness, neurological illness, or scoring less than 8 using the abbreviated mental test (AMT) before operation.
• Severe hearing or visual impairment that may interfere with communication.
• Severe renal or hepatic dysfunction.
• Patients on central nervous system (CNS) medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
• Contraindications to lidocaine or dexmedetomidine \[e.g., allergy, severe bradycardia, atrioventricular (AV) block\].

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Lidocaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Dina H Alhassanin, Master

CONTACT

00201143441294; dhamdy420@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)