Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

Phase 4

Completed

• Conditions: Pregabalin; Dexmedetomidine; Delirium
• Interventions: Drug: Dexmedetomidine; Drug: Pregabalin

• Registration Number: NCT05640479
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2022-11-26
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-07
• Study Start: 2022-12-15
• Status Verified: 2024-03
• Primary Completion: 2024-12-03
• Study Completion: 2025-01-02
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	Dexmedetomidine	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.
pregabalin group	Pregabalin	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Delirium	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 Outcome Measures

Name	Time	Method
Sedation	24 hours postoperatively	Sedation level will be recorded using Sedation Agitation Scale
Length of hospital stay	One month postoperatively	Patients will stay in hospital for one month
Pain score	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 (\'no pain\') and 10 (\'pain as bad as it could possibly be\').
Postoperative opioid consumption	48 hours postoperatively	Patients will receive 0.05mg/kg dose of intravenous morphine given to keep pain scores less than 4

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, ElGharbiaa, Egypt