Delirium, Dexmedetomidine, Pregabalin
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPregabalin
patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 hours
DRUGDexmedetomidine
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
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III scheduled for cardiac surgery.
Exclusion criteria
* Patients who had history of psychiatric diseases; inability to communicate; previous history of POD; preoperative sick sinus syndrome. * Allergy/sensitivity to pregabalin or dexmedetomidine. * Severe bradycardia (heart rate \<50 beat per minute). * Second-degree or above atrioventricular block without pacemaker. * Severe hepatic or renal insufficiency. * Previous cardiac or thoracic surgery. * Known diagnosis of depression or other major psychiatric diseases. * Cognitive impairment or inability to cooperate with the study. * Renal insufficiency, and history of substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation | 24 hours postoperatively | Sedation level will be recorded using Sedation Agitation Scale |
| Length of hospital stay | One month postoperatively | Patients will stay in hospital for one month |
| Pain score | 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'). |
| Postoperative opioid consumption | 48 hours postoperatively | Patients will receive 0.05mg/kg dose of intravenous morphine given to keep pain scores less than 4 |
Countries
Egypt
Outcome results
None listed