Tanta University
Tanta, ElGharbiaa, 31527, Egypt
NCT Number: NCT05640479
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.
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Notify Me65 year and older
All sexes
Interventional
Phase 4
Tanta, ElGharbiaa, 31527, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 hours
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
Time frame: 24 hours postoperatively for five postoperative days
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)
Time frame: 24 hours postoperatively
Sedation level will be recorded using Sedation Agitation Scale
Time frame: One month postoperatively
Patients will stay in hospital for one month
Time frame: 48 hours postoperatively
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').
Time frame: 48 hours postoperatively
Patients will receive 0.05mg/kg dose of intravenous morphine given to keep pain scores less than 4
Time frame: At one month after surgery
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').
Tanta University
Other
Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery: A Randomized Double-Blind Trial
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