Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

NCT05640479 | Completed Phase 4

• 1 other identifier: 35913/10/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregabalin; Dexmedetomidine; Delirium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Sedation

  24 hours postoperatively

• Length of hospital stay

  One month postoperatively

• Pain score

  48 hours postoperatively

• Postoperative opioid consumption

  48 hours postoperatively

• Pain score

  At one month after surgery

Study Arms (2)

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.

Drug: Pregabalin

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.

Drug: Dexmedetomidine

Interventions

Pregabalin DRUG

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

pregabalin group

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

dexmedetomidine group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III scheduled for cardiac surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Conditions

Delirium

Interventions

Pregabalin; Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Doha M Bakr, MD

  Lecturer of Anesthesiology

  PRINCIPAL INVESTIGATOR

• Osama M Rehab, MD

  Lecturer of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Egypt

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 7, 2022
• Study Start: December 15, 2022
• Primary Completion: December 3, 2024
• Study Completion: January 2, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: for one year after completion of the study

Locations

EG (1)