Anesthesia, IntravenousNCT03428191
Target Effect-site Concentration of Remifentanil in Transperineal Prostate Puncture
An observational study of Anesthesia, Intravenous, run by Chinese Medical Association at 1 site in China.
Trial summary
The research about the target effect-site concentration of remifentanil, inhibiting stress reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Anesthesia, Intravenous
- What is being tested?
- Remifentanyl+Dexmedetomidine
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Feb 2018
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients of perineal prostate puncture
Who may be able to join
- patients of perineal prostate puncture
Who cannot join
- sinus bradycardia or atrioventricular block serious heart, brain, lung, liver, kidney, and metabolic disease allergy for dexmedetomidine or opioid
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Yi Liu, 13386277602
About this study
Official title: The Research About the Target Effect-site Concentration of Remifentanil Inhibiting Stress Reaction of the Perineal Prostate Puncture When Dexmedetomidine Being Continuous Pumping
The research about the target effect-site concentration of remifentanil, inhibiting stress reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping
Read the detailed description
Patients who were scheduled to undergo transperineal prostate puncture and biopsy were recruited into our study. In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method. The first target effect-site concentration of remifentanil was set to 4.5ng/ml, the difference of adjacent target concentration was 0.5 ng/ml. Cardiovascular positive reaction was defined as the changes of heart rate or systolic blood pressure was more than 15% compared with baseline values, or body movement observed. The adjacent target concentration difference was adjusted to 0.2 ng/ml after 3 negative and positive reaction cycles. If the first had a cardiovascular positive reaction, the target concentration of remifentanil increased by a concentration gradient. Conversely, the target concentration of remifentanil decreased by a concentration gradient.
- Conditions
- Anesthesia, Intravenous
- Being tested
- Remifentanyl+Dexmedetomidine
- Keywords
- dexmedetomidine, remifentanil, prostate puncture and biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanyl+DexmedetomidineDrug
Also called target effect-site concentration of remifentanil
In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method.
What is being measured
The primary outcome is the main question the study is designed to answer.
the target effect-site concentration of remifentanil
the target Effect-site concentration of remifentanil was determined by sequential method.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study startJan 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, IntravenousStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Liu Yi, D.M, Study director, Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428191
- Sponsor's protocol ID
- MAC-0109
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research About the Target Effect-site Concentration of Remifentanil Inhibiting Stress Reaction of the Perineal Prostate Puncture When Dexmedetomidine Being Continuous Pumping
- ClinicalTrials.gov ID
- NCT03428191
- Acronym / sponsor ID
- MAC-0109
- Conditions
- Anesthesia, Intravenous
- Keywords
- dexmedetomidine, remifentanil, prostate puncture and biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Jan 2017
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 9 Feb 2018 (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.
The research about the target effect-site concentration of remifentanil, inhibiting stress reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping
Detailed description
Patients who were scheduled to undergo transperineal prostate puncture and biopsy were recruited into our study. In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method. The first target effect-site concentration of remifentanil was set to 4.5ng/ml, the difference of adjacent target concentration was 0.5 ng/ml. Cardiovascular positive reaction was defined as the changes of heart rate or systolic blood pressure was more than 15% compared with baseline values, or body movement observed. The adjacent target concentration difference was adjusted to 0.2 ng/ml after 3 negative and positive reaction cycles. If the first had a cardiovascular positive reaction, the target concentration of remifentanil increased by a concentration gradient. Conversely, the target concentration of remifentanil decreased by a concentration gradient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of perineal prostate puncture
Key inclusion criteria (1 listed)
- patients of perineal prostate puncture
Key exclusion criteria (1 listed)
- sinus bradycardia or atrioventricular block serious heart, brain, lung, liver, kidney, and metabolic disease allergy for dexmedetomidine or opioid
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 |
|---|---|---|
| Remifentanyl+DexmedetomidineAlso: target effect-site concentration of remifentanilIn all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method. | Drug | – |
Primary outcome
the target effect-site concentration of remifentanil
Time frame: intraoperative
the target Effect-site concentration of remifentanil was determined by sequential method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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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.
Liu Yi, D.M study director
Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Intravenous, run by Chinese Medical Association 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 9 Feb 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhou (13761293168, littlebaby89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the target effect-site concentration of remifentanil (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2018.