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The aim of this study is to compare the effect of perioperative administration of pregabalin versus dexmedetomidine on the prevalence and lasting duration of delirium in elderly patients after cardiac surgery.
Pregabalin is a beta-isobutyl of GABA with chemical similarity to gabapentin . Pregabalin binds to the alpha-2-delta subgroup of calcium channels, thereby reducing excitatory neurotransmitter release and preventing hyperalgesia and central sensitization . Pregabalin is used as anticonvulsant but has also been used as analgesic for neuropathic pain and, lately, for postoperative pain, in an attempt to reduce opioid consumption and prevent progression to chronic pain.
Dexmedetomidine with its broad range of effects including easily controllable sedation, analgesia, and anxiolysis still enables the caring medical team to interact with the patient. It reduces the activity while still maintaining the reactivity of neurons in the locus coeruleus. Therefore, it is an appealing alternative to traditional sedatives such as propofol and benzodiazepines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin group | Active Comparator | patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 h for 24h postoperatively by nasogastric tube or orally. Patients will receive IV saline as placebo with the same rate of dexmedetomidine. |
|
| dexmedetomidine group | Active Comparator | patients in the dexmedetomidine group will receive after induction of GA a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/kg/h. Patients will receive placebo 2 h prior to induction of anesthesia and every 12 h for 24h postoperatively by nasogastric tube or orally. If patients are hemodynamically unstable, the bolus dose will be omitted. The infusion of dexmedetomidine will be continued for a maximum period of 24 h. Dexmedetomidine infusion will be not discontinued before extubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Delirium | Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM) | 24 hours postoperatively for five postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation | Sedation level will be recorded using Sedation Agitation Scale | 24 hours postoperatively |
| Length of hospital stay | Patients will stay in hospital for one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doha M Bakr, MD | Lecturer of Anesthesiology | Principal Investigator |
| Osama M Rehab, MD | Lecturer of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | ElGharbiaa | 31527 | Egypt |
The data will be upon reasonable request from the principal investigator
for one year after completion of the study
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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The research solutions will be formulated by a devoted pharmacist who had no further involvement in the trial. Intraoperative and postoperative parameters will be examined by a second anesthesiologist who was unaware of group assignment.
| Dexmedetomidine | Drug | patients will receive dexmedetomidine after induction of GA a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/kg/h |
|
| One month postoperatively |
| Pain score | Postoperative pain (using VAS) at rest and movement will be measured after extubation and at 12, 18, 24, and 48 hours after surgery The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | 48 hours postoperatively |
| Postoperative opioid consumption | Patients will receive 0.05mg/kg dose of intravenous morphine given to keep pain scores less than 4 | 48 hours postoperatively |
| Pain score | pain intensity at one month after surgery assessed by the Visual Analogue Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | At one month after surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |