NCT04735965

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 10, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

January 24, 2021

Last Update Submit

December 18, 2021

Conditions

Coronary Artery DiseasePostoperative Shivering

Keywords

Shivering

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative shivering

    The incidence and severity of postoperative shivering and the rescue treatment

    Within postoperative 24 hours

Secondary Outcomes (10)

  • Times of postoperative rescue drugs used

    Within postoperative 24 hours

  • The incidence of postoperative hypotension and bradycardia

    From the administration of experimental drugs to postoperative 24 hours

  • Ramsay sedation score

    Within postoperative 3 days

  • Postoperative extubation time

    The time of extubation

  • Length of stay in the ICU

    The length of stay in ICU within postoperative 30 days

  • +5 more secondary outcomes

Study Arms (3)

Dexmedetomidine group

EXPERIMENTAL
Drug: Dexmedetomidine

Meperidine group

ACTIVE COMPARATOR
Drug: Meperidine

Control group

PLACEBO COMPARATOR
Drug: Placeb

Interventions

DexmedetomidineDRUG

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

Dexmedetomidine group
MeperidineDRUG

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

Meperidine group
PlacebDRUG

Equal volume of normal saline to dexmedetomidine and meperidine group.

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China, Shandong Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35149565DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

DexmedetomidineMeperidine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicPiperidines

Central Study Contacts

Cuicui Cao

CONTACT

+8615863187590cccbzyxy@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 3, 2021

Study Start

July 15, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

January 10, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)