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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | Incidence of postoperative delirium (POD) will be recorded. | Three days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Regional cerebral oxygen saturation | 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. | Till end of surgery (Up to 2 hours) |
| Degree of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina H Alhassanin, Master | Contact | 00201143441294 | dhamdy420@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| 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. |
|
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. |
| 24 hours postoperatively |
| Postoperative opioid consumption | 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. | 24 hours postoperatively |
| Heart rate | Heart rate will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery. | Till end of surgery (Up to 2 hours) |
| Mean arterial blood pressure | Mean arterial blood pressure will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery. | Till end of surgery (Up to 2 hours) |
| Incidence of adverse effects | Incidence of adverse effects such as nausea, vomiting, and respiratory depression will be recorded. | 24 hours postoperatively |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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