Clinical trial NCT04735965: Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft
Official title: Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Postoperative Shivering
Keywords: Shivering
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of postoperative shivering
timeFrame: Within postoperative 24 hours
Secondary outcomes:
measure: Times of postoperative rescue drugs used
timeFrame: Within postoperative 24 hours
measure: The incidence of postoperative hypotension and bradycardia
timeFrame: From the administration of experimental drugs to postoperative 24 hours
measure: Ramsay sedation score
timeFrame: Within postoperative 3 days
measure: Postoperative extubation time
timeFrame: The time of extubation
measure: Length of stay in the ICU
timeFrame: The length of stay in ICU within postoperative 30 days
measure: The incidence of postoperative delirium
timeFrame: Within postoperative 7 days
measure: The incidence of postoperative arrhythmias
timeFrame: Within postoperative 24 hours
measure: The incidence and severity of postoperative PONV
timeFrame: Within postoperative 3 days
measure: Length of stay
timeFrame: The first day after surgery to discharge
measure: The rate of all-cause death of participants
timeFrame: Within postoperative 30 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: China, Shandong Qianfoshan Hospital
state: Shandong
Study officials:
References:
citation: Cao C, Lv M, Wei C, Yan J, Wang Y, Gu C. Comparison of dexmedetomidine and meperidine for the prevention of shivering following coronary artery bypass graft: study protocol of a randomised controlled trial. BMJ Open. 2022 Feb 11;12(2):e053865. doi: 10.1136/bmjopen-2021-053865.