Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft

Study Overview
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Brief Summary
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This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.

Detailed Description
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Shivering is a common complication in the postoperative period. The incidence of shivering has been reported to range from 5% to 65% under general anesthesia and as 33% during epidural anesthesia. Shivering can increase perioperative risk in patients. Both dexmedetomidine and meperidine are effective agents for the prevention of postanesthetic shivering. However, few studies have compared the anti-shivering effects of different agents following coronary artery bypass graft (CABG). This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.

Official Title
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Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial

Conditions
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Coronary Artery Disease, Postoperative Shivering

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Meperidine
* Drug: Placeb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) aged between 18 and 75 years, (2) undergoing elective CABG, (3) ASA grade of II-IV, and (4) in accordance with ethical guidelines, patients must voluntarily participate in the trial and sign the informed consent for the clinical study. Exclusion Criteria: (1) patients with neurological or psychiatric disorders, (2) hepatic and renal dysfunction, (3) severe hyperthyroidism or hypothyroidism, (4) a body temperature greater than 38 °C or less than 36 °C, (5) postoperative hemodynamic instability, (6) preoperative use of a left ventricular assistance device, (7) pa severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, diabetic nephropathy), (8) participation in other clinical studies within the past 3 months, (9) acute or chronic pain, (10) addiction to opioids, (11) drug abuse, (12) pain management, and (13) neuromuscular disease, (14) on-pump CABG.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine group<br> | Drug: Dexmedetomidine<br>* Dexmedetomidine would be intravenously infused at a dose of 1μg/kg over 15 minutes 30 min before the end of surgery<br>|
| Active Comparator: Meperidine group<br> | Drug: Meperidine<br>* Meperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery<br>|
| Placebo Comparator: Control group<br> | Drug: Placeb<br>* Equal volume of normal saline to dexmedetomidine and meperidine group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative shivering | The incidence and severity of postoperative shivering and the rescue treatment | Within postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times of postoperative rescue drugs used |  | Within postoperative 24 hours | 
| The incidence of postoperative hypotension and bradycardia |  | From the administration of experimental drugs to postoperative 24 hours | 
| Ramsay sedation score | The minimum and maximum score are 1 and 6, respectively. Score 1 represents that patients is anxious and agitated or restless , or both. And score 6 represents that patients exhibits no response. | Within postoperative 3 days | 
| Postoperative extubation time |  | The time of extubation | 
| Length of stay in the ICU |  | The length of stay in ICU within postoperative 30 days | 
| The incidence of postoperative delirium |  | Within postoperative 7 days | 
| The incidence of postoperative arrhythmias |  | Within postoperative 24 hours | 
| The incidence and severity of postoperative PONV |  | Within postoperative 3 days | 
| Length of stay |  | The first day after surgery to discharge | 
| The rate of all-cause death of participants |  | Within postoperative 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shivering