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

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04735965
Collaborator
(none)
180
1
3
12.6
14.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine group

Drug: Dexmedetomidine
Dexmedetomidine would be intravenously infused at a dose of 1μg/kg over 15 minutes 30 min before the end of surgery

Active Comparator: Meperidine group

Drug: Meperidine
Meperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery

Placebo Comparator: Control group

Drug: Placeb
Equal volume of normal saline to dexmedetomidine and meperidine group.

Outcome Measures

Primary Outcome Measures

  1. The incidence of postoperative shivering [Within postoperative 24 hours]

    The incidence and severity of postoperative shivering and the rescue treatment

Secondary Outcome Measures

  1. Times of postoperative rescue drugs used [Within postoperative 24 hours]

  2. The incidence of postoperative hypotension and bradycardia [From the administration of experimental drugs to postoperative 24 hours]

  3. 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.

  4. Postoperative extubation time [The time of extubation]

  5. Length of stay in the ICU [The length of stay in ICU within postoperative 30 days]

  6. The incidence of postoperative delirium [Within postoperative 7 days]

  7. The incidence of postoperative arrhythmias [Within postoperative 24 hours]

  8. The incidence and severity of postoperative PONV [Within postoperative 3 days]

  9. Length of stay [The first day after surgery to discharge]

  10. The rate of all-cause death of participants [Within postoperative 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 China, Shandong Qianfoshan Hospital Jinan Shandong China 250014

Sponsors and Collaborators

  • Qianfoshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lili Cao, Professor, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT04735965
Other Study ID Numbers:
  • DMCABG
First Posted:
Feb 3, 2021
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lili Cao, Professor, Qianfoshan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022