Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery: A Randomized Double-Blind Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium; Dexmedetomidine; Pregabalin
• Intervention / Treatment: Drug: Pregabalin; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Islam Morsy, MD; Phone Number: 00201093387374; Email: eslam.morsy@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Pregabalin; patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 hours
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Postoperative pain (using VAS) at rest and movement will be measured at PACU, 1h, 2hr. 4hr, 6hr, 8hr, 12hr, 18hr, and 24hrs postoperative. 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').	24 hours postoperatively
Postoperative opioid consumption	Patients will receive single 3 mg dose of intravenous morphine and patient control analgesia (PCA) will be started with a programmable PCA pump using the following settings: basal morphine infusion 1 mg/h, bolus dose 1 mg, and lockout time 20 minutes.	24 hours postoperatively
Sedation	Sedation level will be recorded using Sedation Agitation Scale	24 hours postoperatively
Length of hospital stay	Patients will stay in hospital for one month	One month postoperatively

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohammed S El Sharkawy, MD, Assistant Lecturer of Anesthesiology; Principal Investigator: Hussein G Almawardy, MD, lecturer of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2022
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: November 26, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Estimate): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Dexmedetomidine; Pregabalin
• Other Study ID Numbers: 35913/10/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be upon reasonable request from the principal investigator
• IPD Sharing Time Frame: for one year after completion of the study
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No