Pharmacodynamic InteractionPhase 4PIPDIANCT02777619
Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia
A Phase 4 study testing 0.0ng/ml Dexmedetomidine, 0.4ng/ml Dexmedetomidine and 0.6ng/ml Dexmedetomidine in people with Pharmacodynamic Interaction, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
The purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamic Interaction
- What is being tested?
- 0.0ng/ml Dexmedetomidine, 0.4ng/ml Dexmedetomidine and 0.6ng/ml Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jul 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight:18≦ BMI≦25
- Written informed consent from the patient or the relatives of the participating patient.
Who cannot join
- A previous history of intolerance to the study drug or related compounds and additives.
- Existing significant haematological, endocrine, metabolic or gastrointestinal disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
About this study
Official title: Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Target-controlled Infusion Intravenous Anesthesia During the Induction
The purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50).
Read the detailed description
64 cases were randomly divided into four groups, In each group, dexmedetomidine target plasma concentration are 0, 0.4, 0.6, 0.8 ng/ml. Dexmedetomidine administered 15 min before target controlled infusion of propofol. The propofol infusion was started to provide a target effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness when the effect-site concentration and target concentration equilibrium.
- Conditions
- Pharmacodynamic Interaction
- Being tested
- 0.0ng/ml Dexmedetomidine, 0.4ng/ml Dexmedetomidine, 0.6ng/ml Dexmedetomidine, 0.8ng/ml Dexmedetomidine, Propofol
- Keywords
- Pharmacodynamic, Dexmedetomidine, Propofol, Target-controlled Infusion Intravenous Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.0ng/ml DexmedetomidineDrug
Dexmedetomidine target plasma concentration is 0.0ng/ml
0.4ng/ml DexmedetomidineDrug
Dexmedetomidine target plasma concentration is 0.4ng/ml
0.6ng/ml DexmedetomidineDrug
Dexmedetomidine target plasma concentration is 0.6ng/ml
0.8ng/ml DexmedetomidineDrug
Dexmedetomidine target plasma concentration is 0.8ng/ml
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Propofol and 0.0ng/ml Dexmedetomidine | Placebo comparator | Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.0ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. Receives: Drug: 0.0ng/ml Dexmedetomidine; Drug: Propofol |
| Propofol and 0.4ng/ml Dexmedetomidine | Experimental | Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.4ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. Receives: Drug: 0.4ng/ml Dexmedetomidine; Drug: Propofol |
| Propofol and 0.6ng/ml Dexmedetomidine | Experimental | Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.6ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. Receives: Drug: 0.6ng/ml Dexmedetomidine; Drug: Propofol |
| Propofol and 0.8ng/ml Dexmedetomidine | Experimental | Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.8ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. Receives: Drug: 0.8ng/ml Dexmedetomidine; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The EC50 of propofol for loss of consciousness
The aim of the investigators study is to define the optimum target concentration (EC50) of propofol for loss of consciousness with different dexmedetomidine target plasm concentration.
Measured: within 30 min during the induction of anesthesia
Secondary outcomes (1)
The EC95 of propofol for loss of consciousness
The aim of the investigators study is to define the optimum target concentration (EC95) of propofol for loss of consciousness with different dexmedetomidine target plasm concentration.
Measured: within 30 min during the induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pharmacodynamic InteractionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777619
- Sponsor's protocol ID
- Pharmacodynamic Interactions
- Acronym
- PIPDIA
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chen Z, Shao DH, Hang LH. Effects of dexmedetomidine on performance of bispectral index as an indicator of loss of consciousness during propofol administration. Swiss Med Wkly. 2013 Mar 14;143:w13762. doi: 10.4414/smw.2013.13762. eCollection 2013.
PubMed 23519436Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740.
PubMed 26068206
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Target-controlled Infusion Intravenous Anesthesia During the Induction
- ClinicalTrials.gov ID
- NCT02777619
- Acronym / sponsor ID
- PIPDIA / Pharmacodynamic Interactions
- Conditions
- Pharmacodynamic Interaction
- Keywords
- Pharmacodynamic, Dexmedetomidine, Propofol, Target-controlled Infusion Intravenous Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 May 2016 (estimated)
- 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 purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50).
Detailed description
64 cases were randomly divided into four groups, In each group, dexmedetomidine target plasma concentration are 0, 0.4, 0.6, 0.8 ng/ml. Dexmedetomidine administered 15 min before target controlled infusion of propofol. The propofol infusion was started to provide a target effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness when the effect-site concentration and target concentration equilibrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Propofol and 0.0ng/ml Dexmedetomidine | Placebo comparator | Drug: 0.0ng/ml Dexmedetomidine, Drug: PropofolPropofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.0ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. |
| Propofol and 0.4ng/ml Dexmedetomidine | Experimental | Drug: 0.4ng/ml Dexmedetomidine, Drug: PropofolPropofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.4ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. |
| Propofol and 0.6ng/ml Dexmedetomidine | Experimental | Drug: 0.6ng/ml Dexmedetomidine, Drug: PropofolPropofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.6ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. |
| Propofol and 0.8ng/ml Dexmedetomidine | Experimental | Drug: 0.8ng/ml Dexmedetomidine, Drug: PropofolPropofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.8ng/ml administered for 15min, and increased by 0.2ug/ml until the patient's consciousness disappears. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weight:18≦ BMI≦25
- Written informed consent from the patient or the relatives of the participating patient.
Key exclusion criteria (2 listed)
- A previous history of intolerance to the study drug or related compounds and additives.
- Existing significant haematological, endocrine, metabolic or gastrointestinal disease.
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 |
|---|---|---|
| 0.0ng/ml DexmedetomidineDexmedetomidine target plasma concentration is 0.0ng/ml | Drug | Propofol and 0.0ng/ml Dexmedetomidine |
| 0.4ng/ml DexmedetomidineDexmedetomidine target plasma concentration is 0.4ng/ml | Drug | Propofol and 0.4ng/ml Dexmedetomidine |
| 0.6ng/ml DexmedetomidineDexmedetomidine target plasma concentration is 0.6ng/ml | Drug | Propofol and 0.6ng/ml Dexmedetomidine |
| 0.8ng/ml DexmedetomidineDexmedetomidine target plasma concentration is 0.8ng/ml | Drug | Propofol and 0.8ng/ml Dexmedetomidine |
| Propofol | Drug | Propofol and 0.0ng/ml Dexmedetomidine, Propofol and 0.4ng/ml Dexmedetomidine, Propofol and 0.6ng/ml Dexmedetomidine, Propofol and 0.8ng/ml Dexmedetomidine |
Primary outcome
The EC50 of propofol for loss of consciousness
Time frame: within 30 min during the induction of anesthesia
The aim of the investigators study is to define the optimum target concentration (EC50) of propofol for loss of consciousness with different dexmedetomidine target plasm concentration.
1 secondary outcome
The EC95 of propofol for loss of consciousness
Time frame: within 30 min during the induction of anesthesia
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 28 Jul 2016.
- Background: PubMed 23519436Chen Z, Shao DH, Hang LH. Effects of dexmedetomidine on performance of bispectral index as an indicator of loss of consciousness during propofol administration. Swiss Med Wkly. 2013 Mar 14;143:w13762. doi: 10.4414/smw.2013.13762. eCollection 2013.
- Background: PubMed 26068206Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740.
- 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.
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 Phase 4 study testing 0.0ng/ml Dexmedetomidine, 0.4ng/ml Dexmedetomidine and 0.6ng/ml Dexmedetomidine in people with Pharmacodynamic Interaction, run by Guangzhou General Hospital of Guangzhou Military Command 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 2 inclusion and 2 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 28 Jul 2016. 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?
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 EC50 of propofol for loss of consciousness (time frame: within 30 min during the induction of anesthesia). 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 NCT02777619, which also lists 2 linked publications.
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 28 Jul 2016.