Clinical trial NCT05640479: Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery
Official title: Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregabalin
Dexmedetomidine
Delirium
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Delirium
timeFrame: 24 hours postoperatively for five postoperative days
Secondary outcomes:
measure: Sedation
timeFrame: 24 hours postoperatively
measure: Length of hospital stay
timeFrame: One month postoperatively
measure: Pain score
timeFrame: 48 hours postoperatively
measure: Postoperative opioid consumption
timeFrame: 48 hours postoperatively
measure: Pain score
timeFrame: At one month after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: ElGharbiaa
Study officials:
affiliation: Lecturer of Anesthesiology
name: Doha M Bakr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Anesthesiology
name: Osama M Rehab, MD
role: PRINCIPAL_INVESTIGATOR
References: