Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07108764

Effect of Intraoperative Infusion of Lidocaine or Dexmedetomidine on Brain Oxygen Levels and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries

Led by Tanta University · Updated on 2025-08-07

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying elderly patients aged 65 and older undergoing major abdominal surgeries to compare the effects of two medications, lidocaine and dexmedetomidine, given during surgery. The study aims to see how these drugs influence the occurrence of postoperative delirium, a common complication after surgery, and how they affect brain oxygen levels during the operation. This research is important because maintaining brain oxygen and reducing delirium may improve recovery in older patients. Participants will be randomly assigned to receive either lidocaine or dexmedetomidine through an intravenous infusion. Lidocaine is given as a 1 mg/kg dose over 10 minutes before anesthesia, followed by a continuous infusion of 1.5 mg/kg per hour until surgery ends. Dexmedetomidine is administered as a 0.5 mcg/kg dose over 10 minutes before anesthesia, then infused at 0.3 mcg/kg per hour during surgery. Both treatments are given intravenously during the operation. During the study, participants will be monitored for brain oxygen saturation levels using near-infrared spectroscopy throughout the surgery, which can last up to two hours. Researchers will also assess the incidence of postoperative delirium for three days after surgery, measure pain and opioid use in the first 24 hours after surgery, and record heart rate, blood pressure, and any adverse effects during and after the operation. This detailed monitoring helps evaluate how each medication impacts brain function and recovery in elderly surgical patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Both sexes
  • Physical status II or III according to the American Society of Anesthesiologists (ASA)
  • Undergoing elective non-cardiac surgeries
Not Eligible

You will not qualify if you...

  • History of mental illness or neurological illness
  • Scoring less than 8 on the abbreviated mental test before operation
  • Severe hearing or visual impairment interfering with communication
  • Severe kidney or liver dysfunction
  • Use of central nervous system medications such as antipsychotics, anticonvulsants, antiparkinsonian drugs, or antidepressants
  • Contraindications to lidocaine or dexmedetomidine such as allergy, severe slow heart rate, or atrioventricular (AV) block

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 hours (duration of surgery)

Participants receive an IV bolus of either lidocaine or dexmedetomidine before anesthesia induction, followed by an intraoperative infusion of the assigned drug until the end of surgery.

1 intraoperative treatment period

Follow-up

Duration - 24 hours postoperatively

Participants are monitored for postoperative delirium, pain levels, opioid consumption, and adverse effects for 24 hours after surgery.

1 follow-up visit within 24 hours after surgery

Trial Site Locations

Total: 1 location

1

Tanta University

Tanta, El-Gharbia, Egypt, 31527

Actively Recruiting

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Research Team

D

Dina H Alhassanin, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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