Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640479

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregabalin Dexmedetomidine Delirium	Drug: Pregabalin Drug: Dexmedetomidine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

May 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of Delirium [24hour postoperatively]
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

Pain score [24 hours postoperatively]
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').
Postoperative opioid consumption [24 hours postoperatively]
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: Mohammed S El Sharkawy, MD, Assistant Lecturer of Anesthesiology
Principal Investigator: Hussein G Almawardy, MD, Lecturer of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Islam Morsy, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Egypt, Tanta University

ClinicalTrials.gov Identifier:

NCT05640479

Other Study ID Numbers:

35913/10/22

First Posted:

Dec 7, 2022

Last Update Posted:

Dec 7, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Pregabalin

Dexmedetomidine

Study Results

No Results Posted as of Dec 7, 2022