Effect of Dexmedetomidine on Central Nervous System Complications in Patients Undergoing Cardiac Surgery

NCT06551259 | Completed Phase 4

• 1 other identifier: PLAGH-DEX-RCT-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

With the continuous improvement of medical technology, more and more patients need to undergo surgery as a kind of treatment for their diseases. However, there are various pains that may occur in the perioperative period, risks associated with anesthesia, loss of body organs, surgical trauma, and postoperative procedures Factors such as the onset of the disease can cause the vast majority of patients to have varying degrees of emotional reactions such as worry, worry, nervousness, and fear. Emotional disorders such as depressed mood, disappointed crying, decreased mobility, and delayed thinking and cognitive function, that is, postoperative psychiatric symptoms. Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine. Releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. Previous studies have shown that dexmedetomidine is lowering. DEX has the potential to prevent and treat patients undergoing cardiac surgery. The role of postoperative anxiety and depression needs to be further explored for evidence-based evidence. Based on the above research background, the hypothesis of this study is proposed. The intraoperative use of dexmedetomidine has a positive effect on alleviating postoperative anxiety and depression in patients undergoing postoperative cardiac surgery.

Conditions

Randomized Controlled Trial; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative depression

  Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms

  Postoperative 7 days and 30 days

Secondary Outcomes (7)

• The incidence of postoperative anxiety

  Postoperative 7 days and 30 days

• The incidence of postoperative delirium

  Postoperative 7 days

• Postoperative Pain

  Postoperative 7 days and 30 days

• Postoperative quality of life evaluation

  Postoperative 30 days

• Postoperative mortality rate

  Postoperative 7 days and 30 days

Study Arms (2)

Intervention group: dexmedetomidine

EXPERIMENTAL

Intravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

Provide equal volume of physiological saline

Drug: physiological saline

Interventions

Dexmedetomidine DRUG

Intravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery

Intervention group: dexmedetomidine

physiological saline DRUG

physiological saline

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18 to 85 years old, regardless of gender
• Patients who undergo cardiac surgery on a scheduled basis;
• ASA level 1-4;
• Obtain written informed consent form;

You may not qualify if:

• Patients with MMSE scores less than 18 or dementia, intellectual disability, and inability to communicate (coma, severe dementia, hearing or language impairment);
• Have a history of mental or neurological disorders (such as schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis);
• Previous history of brain injury;
• Severe liver dysfunction (Child pugh C-grade) or renal insufficiency (preoperative dialysis);
• Severe bradycardia (heart rate below 50 beats per minute), pathological sinus syndrome, or atrioventricular block without a pacemaker;
• Postoperative intensive care unit (ICU) duration exceeding 7 days or death;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• WEIDONG MI, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: January 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)