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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735965
• Other study ID #: DMCABG
• Status: Recruiting
• Phase: Phase 4
• Start date: July 15, 2021
• Est. completion date: August 2022

Study information

• Verified date: December 2021
• Source: Qianfoshan Hospital
• Contact: Cuicui Cao
• Phone: +8615863187590
• Email: cccbzyxy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Postoperative Shivering

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine would be intravenously infused at a dose of 1µg/kg over 15 minutes 30 min before the end of surgery
• Meperidine
Meperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery
• Placeb
Equal volume of normal saline to dexmedetomidine and meperidine group.

Locations

Country	Name	City	State
China	China, Shandong Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative shivering	The incidence and severity of postoperative shivering and the rescue treatment	Within postoperative 24 hours
Secondary	Times of postoperative rescue drugs used		Within postoperative 24 hours
Secondary	The incidence of postoperative hypotension and bradycardia		From the administration of experimental drugs to postoperative 24 hours
Secondary	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
Secondary	Postoperative extubation time		The time of extubation
Secondary	Length of stay in the ICU		The length of stay in ICU within postoperative 30 days
Secondary	The incidence of postoperative delirium		Within postoperative 7 days
Secondary	The incidence of postoperative arrhythmias		Within postoperative 24 hours
Secondary	The incidence and severity of postoperative PONV		Within postoperative 3 days
Secondary	Length of stay		The first day after surgery to discharge
Secondary	The rate of all-cause death of participants		Within postoperative 30 days