Coronary Artery DiseasePhase 4NCT04735965
Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft
A Phase 4 study testing Dexmedetomidine, Meperidine and Placeb in people with Coronary Artery Disease and Postoperative Shivering, run by Qianfoshan Hospital at 1 site in China.
Trial summary
This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Postoperative Shivering
- What is being tested?
- Dexmedetomidine, Meperidine and Placeb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Shandong Qianfoshan Hospital
Jinan, Shandong, 250014
Lili Cao, qykyc309@163.com
Changping Gu
About this study
Official title: Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial
This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.
Read the 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.
- Conditions
- Coronary Artery Disease, Postoperative Shivering
- Being tested
- Dexmedetomidine, Meperidine, Placeb
- Keywords
- Shivering
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine would be intravenously infused at a dose of 1μg/kg over 15 minutes 30 min before the end of surgery
MeperidineDrug
Meperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery
PlacebDrug
Equal volume of normal saline to dexmedetomidine and meperidine group.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Meperidine group | Active comparator | Not described Receives: Drug: Meperidine |
| Control group | Placebo comparator | Not described Receives: Drug: Placeb |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative shivering
The incidence and severity of postoperative shivering and the rescue treatment
Measured: Within postoperative 24 hours
Secondary outcomes (10)
Times of postoperative rescue drugs used
Measured: Within postoperative 24 hours
The incidence of postoperative hypotension and bradycardia
Measured: From the administration of experimental drugs to postoperative 24 hours
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.
Measured: Within postoperative 3 days
Postoperative extubation time
Measured: The time of extubation
Length of stay in the ICU
Measured: The length of stay in ICU within postoperative 30 days
The incidence of postoperative delirium
Measured: Within postoperative 7 days
The incidence of postoperative arrhythmias
Measured: Within postoperative 24 hours
The incidence and severity of postoperative PONV
Measured: Within postoperative 3 days
Length of stay
Measured: The first day after surgery to discharge
The rate of all-cause death of participants
Measured: Within postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start15 Jul 2021
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735965
- Sponsor's protocol ID
- DMCABG
- Status last verified
- Dec 2021
- First submitted
- 24 Jan 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35149565
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04735965
- Acronym / sponsor ID
- DMCABG
- Conditions
- Coronary Artery Disease, Postoperative Shivering
- Keywords
- Shivering
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine |
| Meperidine group | Active comparator | Drug: Meperidine |
| Control group | Placebo comparator | Drug: Placeb |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine would be intravenously infused at a dose of 1μg/kg over 15 minutes 30 min before the end of surgery | Drug | Dexmedetomidine group |
| MeperidineMeperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery | Drug | Meperidine group |
| PlacebEqual volume of normal saline to dexmedetomidine and meperidine group. | Drug | Control group |
Primary outcome
The incidence of postoperative shivering
Time frame: Within postoperative 24 hours
The incidence and severity of postoperative shivering and the rescue treatment
10 secondary outcomes
Times of postoperative rescue drugs used
Time frame: Within postoperative 24 hours
The incidence of postoperative hypotension and bradycardia
Time frame: From the administration of experimental drugs to postoperative 24 hours
Ramsay sedation score
Time frame: Within postoperative 3 days
Postoperative extubation time
Time frame: The time of extubation
Length of stay in the ICU
Time frame: The length of stay in ICU within postoperative 30 days
The incidence of postoperative delirium
Time frame: Within postoperative 7 days
The incidence of postoperative arrhythmias
Time frame: Within postoperative 24 hours
The incidence and severity of postoperative PONV
Time frame: Within postoperative 3 days
Length of stay
Time frame: The first day after surgery to discharge
The rate of all-cause death of participants
Time frame: Within postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 35149565Cao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Meperidine and Placeb in people with Coronary Artery Disease and Postoperative Shivering, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cuicui Cao (+8615863187590, cccbzyxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative shivering (time frame: Within postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.