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NCT Number: NCT07108764

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

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ahmed M El-Sheikh, MD

SUB_INVESTIGATOR

Ashraf E Alzeftawy, MD

SUB_INVESTIGATOR

Atteia G Ibrahim, MD

SUB_INVESTIGATOR

Dina H Alhassanin, Master

CONTACT

[email protected]

00201143441294

Laila A Elahwal, MD

SUB_INVESTIGATOR

About this study

Postoperative delirium (POD) is a significant complication in elderly patients undergoing major surgery, with an incidence ranging from 10% to 50%, depending on patient and surgical factors.

Regional cerebral oxygen saturation (rSO₂), measured using near-infrared spectroscopy (NIRS), provides a real-time, non-invasive marker of cerebral perfusion. Previous studies have demonstrated that intraoperative declines in rSO₂ are associated with an increased risk of POD.

Lidocaine, an amide local anesthetic, has been shown to reduce neuroinflammation, improve microcirculation, and exert neuroprotective effects. It has been associated with low postoperative pain, reduced opioid consumption, and improved cognitive outcomes.

Dexmedetomidine, an α2-adrenergic agonist, is known for its sedative, analgesic, and sympatholytic effects. It has been shown to enhance cerebral perfusion, improve rSO₂, and reduce POD incidence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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].

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: Three days after surgery

    Incidence of postoperative delirium (POD) will be recorded.

Secondary outcomes

  1. Regional cerebral oxygen saturation

    Time frame: Till end of surgery (Up to 2 hours)

    Regional cerebral oxygen saturation (rScO2) will be recorded using cerebral oximetry at the baseline, 5 min after induction of general anesthesia, then every 20 min till the end of surgery.

  2. Degree of pain

    Time frame: 24 hours postoperatively

    Postoperative numerical rate scale (NRS) score will be recorded on admission to the post-anesthesia care unit (PACU), at six h, 12h, and 24h postoperatively.

  3. Postoperative opioid consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia in the from 3 mg IV morphine (mg) will be given if the numerical rate scale (NRS) is ≥ 4 repeated with 10 10-minute lock-out interval till the NRS becomes less than 3.

  4. Heart rate

    Time frame: Till end of surgery (Up to 2 hours)

    Heart rate will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery.

  5. Mean arterial blood pressure

    Time frame: Till end of surgery (Up to 2 hours)

    Mean arterial blood pressure will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery.

  6. Incidence of adverse effects

    Time frame: 24 hours postoperatively

    Incidence of adverse effects such as nausea, vomiting, and respiratory depression will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Dina H Alhassanin, Master

CONTACT

[email protected]

00201143441294

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

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.

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