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

Primary Purpose

Coronary Artery Disease, Postoperative Shivering

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Meperidine
Placeb
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Shivering

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China, Shandong Qianfoshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine group

Meperidine group

Control group

Arm Description

Outcomes

Primary Outcome Measures

The incidence of postoperative shivering
The incidence and severity of postoperative shivering and the rescue treatment

Secondary Outcome Measures

Times of postoperative rescue drugs used
The incidence of postoperative hypotension and bradycardia
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.
Postoperative extubation time
Length of stay in the ICU
The incidence of postoperative delirium
The incidence of postoperative arrhythmias
The incidence and severity of postoperative PONV
Length of stay
The rate of all-cause death of participants

Full Information

First Posted
January 24, 2021
Last Updated
December 18, 2021
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04735965
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Postoperative Shivering
Keywords
Shivering

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Title
Meperidine group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine would be intravenously infused at a dose of 1μg/kg over 15 minutes 30 min before the end of surgery
Intervention Type
Drug
Intervention Name(s)
Meperidine
Intervention Description
Meperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery
Intervention Type
Drug
Intervention Name(s)
Placeb
Intervention Description
Equal volume of normal saline to dexmedetomidine and meperidine group.
Primary Outcome Measure Information:
Title
The incidence of postoperative shivering
Description
The incidence and severity of postoperative shivering and the rescue treatment
Time Frame
Within postoperative 24 hours
Secondary Outcome Measure Information:
Title
Times of postoperative rescue drugs used
Time Frame
Within postoperative 24 hours
Title
The incidence of postoperative hypotension and bradycardia
Time Frame
From the administration of experimental drugs to postoperative 24 hours
Title
Ramsay sedation score
Description
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.
Time Frame
Within postoperative 3 days
Title
Postoperative extubation time
Time Frame
The time of extubation
Title
Length of stay in the ICU
Time Frame
The length of stay in ICU within postoperative 30 days
Title
The incidence of postoperative delirium
Time Frame
Within postoperative 7 days
Title
The incidence of postoperative arrhythmias
Time Frame
Within postoperative 24 hours
Title
The incidence and severity of postoperative PONV
Time Frame
Within postoperative 3 days
Title
Length of stay
Time Frame
The first day after surgery to discharge
Title
The rate of all-cause death of participants
Time Frame
Within postoperative 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cuicui Cao
Phone
+8615863187590
Email
cccbzyxy@163.com
Facility Information:
Facility Name
China, Shandong Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Cao
Email
qykyc309@163.com
First Name & Middle Initial & Last Name & Degree
Changping Gu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35149565
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.
Results Reference
derived

Learn more about this trial

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

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