Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

Tanta University

Status and phase: Completed; Phase 4

Conditions: Delirium; Dexmedetomidine; Pregabalin

Treatments: Drug: Dexmedetomidine; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT05640479

35913/10/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

pregabalin group

Active Comparator group

Description:

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.

Treatment:

Drug: Pregabalin

dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine