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Completed

NCT Number: NCT05640479

Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University

Tanta, ElGharbiaa, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

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

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

Primary outcomes

  1. Incidence of Delirium

    Time frame: 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 outcomes

  1. Sedation

    Time frame: 24 hours postoperatively

    Sedation level will be recorded using Sedation Agitation Scale

  2. Length of hospital stay

    Time frame: One month postoperatively

    Patients will stay in hospital for one month

  3. Pain score

    Time frame: 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').

  4. Postoperative opioid consumption

    Time frame: 48 hours postoperatively

    Patients will receive 0.05mg/kg dose of intravenous morphine given to keep pain scores less than 4

  5. Pain score

    Time frame: At one month after surgery

    pain intensity at one month after surgery assessed by the Visual Analogue Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 (&#39;no pain&#39;) and 10 (&#39;pain as bad as it could possibly be&#39;).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 7, 2022
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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