Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

NCT ID: NCT05640479

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2025-01-02

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.

Conditions

Pregabalin; Dexmedetomidine; Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

pregabalin group

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 hours

dexmedetomidine group

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: 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

Interventions

Pregabalin

patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 hours

Intervention Type: DRUG

Dexmedetomidine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Islam Morsy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doha M Bakr, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anesthesiology

Osama M Rehab, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anesthesiology

Locations

Tanta University

Tanta, ElGharbiaa, Egypt

Countries

Egypt

Other Identifiers

35913/10/22

Identifier Type: -

Identifier Source: org_study_id