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

Phase 4

• Conditions: Coronary Artery Disease; Postoperative Shivering
• Interventions: Drug: Placeb; Drug: Dexmedetomidine; Drug: Meperidine

• Registration Number: NCT04735965
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-07-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-18
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-07
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placeb	-
Dexmedetomidine group	Dexmedetomidine	-
Meperidine group	Meperidine	-

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative shivering	Within postoperative 24 hours	The incidence and severity of postoperative shivering and the rescue treatment

Secondary Outcome Measures

Name	Time	Method
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
Length of stay in the ICU	The length of stay in ICU within postoperative 30 days
The incidence and severity of postoperative PONV	Within postoperative 3 days
The incidence of postoperative arrhythmias	Within postoperative 24 hours
Length of stay	The first day after surgery to discharge
The rate of all-cause death of participants	Within postoperative 30 days
Ramsay sedation score	Within postoperative 3 days	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.
Postoperative extubation time	The time of extubation
The incidence of postoperative delirium	Within postoperative 7 days

Trial Locations

Locations (1)

China, Shandong Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China