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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04735965
Other study ID # DMCABG
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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