AnesthesiaNCT03515876
Dexmedetomidine on Segmental EEG Power Spectra
An observational study of Anesthesia and EEG Power Spectra, run by Zhiyi Zuo at 1 site in China.
Trial summary
To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Anesthesia, EEG Power Spectra
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2018to Jul 2019
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: patients for hysteroscopic examination and surgery under general anesthesia.
Who may be able to join
- American Society of Anesthesiologists Physical status I to II grade.
- body mass index 18 to 25 kg/m2
- no vision or hearing impairment
- will receive general anesthesia
Who cannot join
- with psychological or mental diseases
- with neurological diseases
- treating with steroids or with alcohol dependence.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120
Wang Zhi, MD, Ph.D., 13622740039, wwzz1898@163.com
Zhi Wang
About this study
Official title: The Effects of Dexmedetomidine on Segmental EEG Power Spectra Activity Under Propofol-based Anesthesia
To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status.
Read the detailed description
Three groups of patients undergoing hysteroscopic examination and surgery will be studied: 1) control group, patients will receive propofol intravenous infusion to provide anesthesia; 2) dexmedetomidine 0.5 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia; and 3) dexmedetomidine 1 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia.
Each group will have 20 patients.
General conditions including blood pressure, respiration, and heart rates will be recorded.
EEG power spectra activity will be recorded no-invasively by a Narcotrend EEG monitor.
- Conditions
- Anesthesia, EEG Power Spectra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients will receive intravenous propofol infusion. | |
| Dexmedetomidine 0.5 microgram/kg group | Patients will receive dexmedetomidine 0.5 microgram/kg and then intravenous propofol infusion. | |
| Dexmedetomidine 1 microgram/kg group | Patients will receive dexmedetomidine 1 microgram/kg and then intravenous propofol infusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG power spectra
EEG power spectra monitored no-invasively by Narcotrend
Measured: From prior to anesthesia to 10 min after anesthesia.
Secondary outcomes (3)
Blood pressure
Blood pressure monitored no-invasively
Measured: From prior to anesthesia to 10 min after anesthesia.
Respiration
Monitored no-invasively
Measured: From prior to anesthesia to 10 min after anesthesia.
Heart rates
Monitored no-invasively
Measured: From prior to anesthesia to 10 min after anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start19 Apr 2018
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyi Zuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiyi Zuo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515876
- Sponsor's protocol ID
- 2018-52
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on Segmental EEG Power Spectra Activity Under Propofol-based Anesthesia
- ClinicalTrials.gov ID
- NCT03515876
- Acronym / sponsor ID
- 2018-52
- Conditions
- Anesthesia, EEG Power Spectra
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhiyi ZuoUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 4 May 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.
To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status.
Detailed description
Three groups of patients undergoing hysteroscopic examination and surgery will be studied: 1) control group, patients will receive propofol intravenous infusion to provide anesthesia; 2) dexmedetomidine 0.5 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia; and 3) dexmedetomidine 1 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia.
Each group will have 20 patients.
General conditions including blood pressure, respiration, and heart rates will be recorded.
EEG power spectra activity will be recorded no-invasively by a Narcotrend EEG monitor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients will receive intravenous propofol infusion. |
| Dexmedetomidine 0.5 microgram/kg group | – | –Patients will receive dexmedetomidine 0.5 microgram/kg and then intravenous propofol infusion. |
| Dexmedetomidine 1 microgram/kg group | – | –Patients will receive dexmedetomidine 1 microgram/kg and then intravenous propofol infusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients for hysteroscopic examination and surgery under general anesthesia.
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists Physical status I to II grade.
- body mass index 18 to 25 kg/m2
- no vision or hearing impairment
- will receive general anesthesia
Key exclusion criteria (3 listed)
- with psychological or mental diseases
- with neurological diseases
- treating with steroids or with alcohol dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EEG power spectra
Time frame: From prior to anesthesia to 10 min after anesthesia.
EEG power spectra monitored no-invasively by Narcotrend
3 secondary outcomes
Blood pressure
Time frame: From prior to anesthesia to 10 min after anesthesia.
Respiration
Time frame: From prior to anesthesia to 10 min after anesthesia.
Heart rates
Time frame: From prior to anesthesia to 10 min after anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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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?
An observational study of Anesthesia and EEG Power Spectra, run by Zhiyi Zuo 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 3 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 Apr 2019. 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 Zhi Wang, MD (13622740039, wwzz1898@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG power spectra (time frame: From prior to anesthesia to 10 min after anesthesia.). 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 Apr 2019.