DexmedetomidineNCT04577430
Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period
A study testing Dexmedetomidine and Normal saline in people with Dexmedetomidine and General Anesthesia, run by Yangzhou University at 1 site in China.
Trial summary
Perioperative stress may increase the incidence of adverse events in the cardiovascular system and lead to poor prognosis. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist, which can inhibit stress response and reduce hemodynamic fluctuations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, General Anesthesia, Cardiac Electrophysiology
- What is being tested?
- Dexmedetomidine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2019to 16 Mar 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages ranged from 18 to 65
- ASA I~II
- patients undergoing elective general anesthesia
- the surgery time for 1~3 h
Who cannot join
- Preoperative ECG abnormalities, including QTc ≥440 ms (male), 460ms (female)
- abnormal cardiac conduction, prolonged QT syndrome
- heart disease history, such as pacemaker implantation, unstable angina, congestive heart failure, Heart valve disease
- antiarrhythmic drugs (β-receptor blockers, calcium channel blockers, tricyclic antidepressants, etc.) that can prolong the QT interval taken within one week before surgery
- coronary heart disease, non-sinus Heart rhythm, bradycardia, tachycardia, other arrhythmia, etc
- intraoperative HR≤45 beats/min and need drugs to increase heart rate
Show all 11Show fewer
- previous allergy to dexmedetomidine
- preoperative electrolyte abnormalities
- emergency surgery, neurological or mental disorders , Liver and kidney dysfunction
- patients who use analgesic pumps after surgery
- refusal of patients
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, 225012
About this study
Perioperative stress may increase the incidence of adverse events in the cardiovascular system and lead to poor prognosis. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist, which can inhibit stress response and reduce hemodynamic fluctuations. In different usage plans, dexmedetomidine can have different effects on hemodynamics, myocardial electrical activity, cardiac function. The main purpose was to observe its effects on myocardial electrophysiology and cardiac function during perioperative period. The secondary purpose was to explore the optimal dose of dexmedetomidine that has the least adverse effects on perioperative electrocardia action and cardiac function
- Being tested
- Dexmedetomidine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
The loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
DexmedetomidineDrug
The loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
DexmedetomidineDrug
The loading dose with 1 μg/kg, maintenance dose with 1 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
Normal salineDrug
Normal saline is used to observe the effect on the electrophysiology of the patients' hearts
| Study group | Role | What they receive |
|---|---|---|
| Loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg | Experimental | 10 min before induction of anesthesia,the loading dose of dexmedetomidine is 0.5 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the operation finished. Receives: Drug: Dexmedetomidine |
| Loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg | Experimental | 10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the surgery finished. Receives: Drug: Dexmedetomidine |
| Loading dose with 1 μg/kg, maintenance dose with 1 μg/kg | Experimental | 10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 1 μg/kg per hour during the operation until 0.5 h before the surgery finished. Receives: Drug: Dexmedetomidine |
| Normal saline | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB
All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,at the end of surgery,1h after the surgery finished,24 h after the surgery finished,48 h after the surgery finished,72 h after the surgery finished,1 month after the surgery finished
Measured: during surgery to 1 month after the surgery
Secondary outcomes (9)
The level of Na+,iCa2+
All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished
Measured: perioperative
The level of cardiac circulation efficiency
All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished
Measured: Perioperative
The level of maximum pressure gradient
the time preparing to pump a loading dose,the time after the loading dose finished,the beginning of surgery, 30min after the beginning of surgery,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished
Measured: Perioperative
The level of heart rate
the time preparing to pump a loading dose,the time after the loading dose finished,the beginning of surgery, 30min after the beginning of surgery,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished
Measured: Perioperative
The level of mean arterial blood pressure
Measured: Perioperative
The level of systemic vascular resistance
the time preparing to pump a loading dose,the time after the loading dose finished,the beginning of surgery, 30min after the beginning of surgery,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished
Measured: Perioperative
The time of eyes opening from surgery ending,the whole surgery,anesthesia
Measured: intraoperative
The dosage of propofol and remifentanil
Measured: intraoperative
Total fluid intake from entering the operating room to exiting the PACU
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start8 Sep 2019
- Primary completion1 Feb 2021
- Study completion16 Mar 2021
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 DexmedetomidineStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577430
- Sponsor's protocol ID
- 20200915
- Status last verified
- Mar 2021
- First submitted
- 19 Sep 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tan C, Yan S, Shen J, Wu H, Yu L, Wang Y, Tian S, Zhou W, Wu Y, Zhang Z. Effects of dexmedetomidine on cardiac electrophysiology in patients undergoing general anesthesia during perioperative period: a randomized controlled trial. BMC Anesthesiol. 2022 Aug 25;22(1):271. doi: 10.1186/s12871-022-01811-5.
PubMed 36008759
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period
- ClinicalTrials.gov ID
- NCT04577430
- Acronym / sponsor ID
- 20200915
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 6 Oct 2020 (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.
Perioperative stress may increase the incidence of adverse events in the cardiovascular system and lead to poor prognosis. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist, which can inhibit stress response and reduce hemodynamic fluctuations. In different usage plans, dexmedetomidine can have different effects on hemodynamics, myocardial electrical activity, cardiac function. The main purpose was to observe its effects on myocardial electrophysiology and cardiac function during perioperative period. The secondary purpose was to explore the optimal dose of dexmedetomidine that has the least adverse effects on perioperative electrocardia action and cardiac function
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg | Experimental | Drug: Dexmedetomidine10 min before induction of anesthesia,the loading dose of dexmedetomidine is 0.5 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the operation finished. |
| Loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg | Experimental | Drug: Dexmedetomidine10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the surgery finished. |
| Loading dose with 1 μg/kg, maintenance dose with 1 μg/kg | Experimental | Drug: Dexmedetomidine10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 1 μg/kg per hour during the operation until 0.5 h before the surgery finished. |
| Normal saline | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages ranged from 18 to 65
- ASA I~II
- patients undergoing elective general anesthesia
- the surgery time for 1~3 h
Key exclusion criteria (11 listed)
- Preoperative ECG abnormalities, including QTc ≥440 ms (male), 460ms (female)
- abnormal cardiac conduction, prolonged QT syndrome
- heart disease history, such as pacemaker implantation, unstable angina, congestive heart failure, Heart valve disease
- antiarrhythmic drugs (β-receptor blockers, calcium channel blockers, tricyclic antidepressants, etc.) that can prolong the QT interval taken within one week before surgery
- coronary heart disease, non-sinus Heart rhythm, bradycardia, tachycardia, other arrhythmia, etc
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 |
|---|---|---|
| DexmedetomidineThe loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts | Drug | Loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg |
| DexmedetomidineThe loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts | Drug | Loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg |
| DexmedetomidineThe loading dose with 1 μg/kg, maintenance dose with 1 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts | Drug | Loading dose with 1 μg/kg, maintenance dose with 1 μg/kg |
| Normal salineNormal saline is used to observe the effect on the electrophysiology of the patients' hearts | Drug | Normal saline |
Primary outcome
The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB
Time frame: during surgery to 1 month after the surgery
All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,at the end of surgery,1h after the surgery finished,24 h after the surgery finished,48 h after the surgery finished,72 h after the surgery finished,1 month after the surgery finished
9 secondary outcomes
The level of Na+,iCa2+
Time frame: perioperative
The level of cardiac circulation efficiency
Time frame: Perioperative
The level of maximum pressure gradient
Time frame: Perioperative
The level of heart rate
Time frame: Perioperative
The level of mean arterial blood pressure
Time frame: Perioperative
The level of systemic vascular resistance
Time frame: Perioperative
The time of eyes opening from surgery ending,the whole surgery,anesthesia
Time frame: intraoperative
The dosage of propofol and remifentanil
Time frame: intraoperative
Total fluid intake from entering the operating room to exiting the PACU
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 36008759Tan C, Yan S, Shen J, Wu H, Yu L, Wang Y, Tian S, Zhou W, Wu Y, Zhang Z. Effects of dexmedetomidine on cardiac electrophysiology in patients undergoing general anesthesia during perioperative period: a randomized controlled trial. BMC Anesthesiol. 2022 Aug 25;22(1):271. doi: 10.1186/s12871-022-01811-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal saline in people with Dexmedetomidine and General Anesthesia, run by Yangzhou University 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 31 Aug 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB (time frame: during surgery to 1 month after the surgery). 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 NCT04577430, 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 31 Aug 2021.