Loss of ConsciousnessNCT02783846
The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial
A study testing normal saline, dexmedetomidine 0.5 µg/kg and dexmedetomidine 1.0 µg/kg in people with Loss of Consciousness, run by General Hospital of Ningxia Medical University.
Trial summary
The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Loss of Consciousness
- What is being tested?
- normal saline, dexmedetomidine 0.5 µg/kg and dexmedetomidine 1.0 µg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II
- Aged 18-65 years
- Body Mass Index 18.0～24.5 kg/m2
- Without hearing impairment
Who cannot join
- Bradycardia
- Atrioventricular block
- Neurologic disorder and recent use of psychoactive medication
- Allergic to the drugs
About this study
Official title: The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index
The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.
Read the detailed description
It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.
- Conditions
- Loss of Consciousness
- Being tested
- normal saline, dexmedetomidine 0.5 µg/kg, dexmedetomidine 1.0 µg/kg
- Keywords
- Propofol, Dexmedetomidine, Dose, Bispectral index monitor
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineOther
receive equal volume of normal saline
dexmedetomidine 0.5 µg/kgDrug
receive dexmedetomidine 0.5 µg/kg
dexmedetomidine 1.0 µg/kgDrug
receive dexmedetomidine 1.0 µg/kg
| Study group | Role | What they receive |
|---|---|---|
| Group control | Placebo comparator | 24 eligible patients are received equal volumes of saline intravenously for 10 minutes Receives: Other: normal saline |
| Group dexmedetomidine 0.5 µg/kg | Active comparator | 24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes Receives: Drug: dexmedetomidine 0.5 µg/kg |
| Group dexmedetomidine 1.0 µg/kg | Active comparator | 25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes Receives: Drug: dexmedetomidine 1.0 µg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness
Measured: To infuse dexmedetomidine and saline completely ten minutes after
Secondary outcomes (1)
The bispectral index values when patients loss of consciousness
Measured: To infuse dexmedetomidine and saline completely ten minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
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 Loss of ConsciousnessStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783846
- Sponsor's protocol ID
- MHX00123
- Status last verified
- Aug 2016
- First submitted
- 16 May 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: safety
Publications
Gu Y, Yang F, Zhang Y, Zheng J, Wang J, Li B, Ma T, Cui X, Lu K, Ma H. The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Apr 25;20(1):96. doi: 10.1186/s12871-020-01013-x.
PubMed 32334510
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index
- ClinicalTrials.gov ID
- NCT02783846
- Acronym / sponsor ID
- MHX00123
- Conditions
- Loss of Consciousness
- Keywords
- Propofol, Dexmedetomidine, Dose, Bispectral index monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 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 evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.
Detailed description
It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group control | Placebo comparator | Other: normal saline24 eligible patients are received equal volumes of saline intravenously for 10 minutes |
| Group dexmedetomidine 0.5 µg/kg | Active comparator | Drug: dexmedetomidine 0.5 µg/kg24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes |
| Group dexmedetomidine 1.0 µg/kg | Active comparator | Drug: dexmedetomidine 1.0 µg/kg25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I-II
- Aged 18-65 years
- Body Mass Index 18.0～24.5 kg/m2
- Without hearing impairment
Key exclusion criteria (4 listed)
- Bradycardia
- Atrioventricular block
- Neurologic disorder and recent use of psychoactive medication
- Allergic to the drugs
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 |
|---|---|---|
| normal salinereceive equal volume of normal saline | Other | Group control |
| dexmedetomidine 0.5 µg/kgreceive dexmedetomidine 0.5 µg/kg | Drug | Group dexmedetomidine 0.5 µg/kg |
| dexmedetomidine 1.0 µg/kgreceive dexmedetomidine 1.0 µg/kg | Drug | Group dexmedetomidine 1.0 µg/kg |
Primary outcome
The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness
Time frame: To infuse dexmedetomidine and saline completely ten minutes after
1 secondary outcome
The bispectral index values when patients loss of consciousness
Time frame: To infuse dexmedetomidine and saline completely ten minutes after
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 8 Nov 2016.
- Derived from this study: PubMed 32334510Gu Y, Yang F, Zhang Y, Zheng J, Wang J, Li B, Ma T, Cui X, Lu K, Ma H. The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Apr 25;20(1):96. doi: 10.1186/s12871-020-01013-x.
- Individual participant dataSharing planned: No. safety
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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.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline, dexmedetomidine 0.5 µg/kg and dexmedetomidine 1.0 µg/kg in people with Loss of Consciousness, run by General Hospital of Ningxia Medical University.
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 4 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness (time frame: To infuse dexmedetomidine and saline completely ten minutes after). 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 NCT02783846, 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 8 Nov 2016.