Etomidate is Mixed With PropofolNCT03855267
Etomidate/Propofol Mixture or Propofol Monotherapy Use in Patients Undergoing General Anesthesia
A study testing Propofol 20 MG/ML and Propofol 20 mg/ml , etomidate 2 mg/ml in people with Etomidate is Mixed With Propofol, run by Guolin Wang at 1 site in China.
Trial summary
The purpose of this study was to investigate the effects of different proportions of etomidate/propofol mixture and propofol alone intravenous anesthesia on intraoperative and postoperative physiological indicators and complications, and to find out the optimal use ratio of E/P mixture. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Etomidate is Mixed With Propofol
- What is being tested?
- Propofol 20 MG/ML and Propofol 20 mg/ml , etomidate 2 mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Dec 2019
- 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
- Patients undergoing elective general anesthesia surgery in 3h;
- American Society of Anesthesiologists gradesⅠ~III;
- Aged 18 to 65 years, Body Mass Index 18.5 ~ 29.9kg / m2;
- Hemoglobin 100 ~ 125g / L.
- In line with the ethics, the patients volunteered to take the test and signed the informed consent
Who cannot join
- Identify or suspect abuse or chronic use of narcotic sedatives and analgesics;
- Heart, or liver, or lung, or kidney dysfunction;
- Body mass index> 30kg / m2; or <18.5kg / m2
- Speech, hearing or mental disorders;
- severe diabetes, hyperkalemia ;
- participate in other drug clinical researches in four weeks;
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- Poor compliance, can not complete clinical research by research program.
- Any cerebrovascular accident occurred within 3 months, such as stroke, TIA, etc
- Unstable angina and myocardial infarction occurred within 3 months;
- Having contraindications or allergies to experimental drugs and other narcotic drugs;
- Mental illness, hyperkalemia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zicheng Wang
Tianjin, Tianjin Municipality, 300000
Zicheng wang, MM, 13821112922, 527640484@qq.com
About this study
Official title: Effects of Etomidate/Propofol Mixture or Propofol Monotherapy With Different Proportions on Circulation and Prognosis in Patients Undergoing General Anesthesia
The purpose of this study was to investigate the effects of different proportions of etomidate/propofol mixture and propofol alone intravenous anesthesia on intraoperative and postoperative physiological indicators and complications, and to find out the optimal use ratio of E/P mixture.
Read the detailed description
Propofol is one of the most commonly used intravenous anesthesia drugs clinically, the pharmacokinetic characteristics makes it very suitable for total intravenous anesthesia( TIVA), etomidate belongs to intravenous anesthesia with propofol, is a derivative of the imidazoles, its calm performance is strong, work quickly, no obvious respiratory depression, had little effects on the cardiovascular system, which, therefore, to protect the cardiovascular, maintain hemodynamic stability has a certain advantage. Our previous project showed that propofol and etomidate combined application can maintain stable hemodynamics in patients with better, reduce the occurrence of adverse reactions, can be used within 3 h of surgery anesthesia.The purpose of this study is to use propofol or etomidate/propofol mixture in combination with BIS monitoring to perform general anesthesia maintenance for patients, in order to ensure the appropriate depth of anesthesia, better maintain the hemodynamic stability of patients, reduce adverse reactions, and find the appropriate E/P mixture of the best proportion and dose.
- Conditions
- Etomidate is Mixed With Propofol
- Being tested
- Propofol 20 MG/ML, Propofol 20 mg/ml , etomidate 2 mg/ml
- Keywords
- propofol, etomidate, General anesthesia, mixture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 20 MG/MLDrug
Pump propofol to keep bispectral index within 40 # 60
Propofol 20 mg/ml , etomidate 2 mg/mlDrug
Propofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Propofol 20 mg/ml, recommended anesthesia induction dose of 0.1~0.125 ml/kg, anesthesia maintenance pump speed of 0.2~0.5ml/kg/h. keep bispectral index within 40 # 60 Receives: Drug: Propofol 20 MG/ML |
| GroupB | Active comparator | EP1:3, that is, 10ml etomidate was mixed with 30ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml. Receives: Drug: Propofol 20 mg/ml , etomidate 2 mg/ml |
| Group C | Active comparator | EP1:1, that is, 20ml etomidate was mixed with 20ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml. Receives: Drug: Propofol 20 mg/ml , etomidate 2 mg/ml |
| Group D | Active comparator | EP3:1, that is, 30ml etomidate was mixed with 10ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml. Receives: Drug: Propofol 20 mg/ml , etomidate 2 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
the blood pressure is recorded (mmHg)
Measured: intraoperative
heart rate
the heart rate is recorded(bpm)
Measured: intraoperative
Secondary outcomes (1)
Perioperative complications
the incidence of injection pain #nausea and vomit#intraoperative awareness and postoperative agitation.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Jan 2019
- Primary completion31 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Etomidate is Mixed With PropofolStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guolin Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, MD.PHD, Study director, Tainjin Medical University General Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855267
- Sponsor's protocol ID
- GWang007
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Etomidate/Propofol Mixture or Propofol Monotherapy With Different Proportions on Circulation and Prognosis in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03855267
- Acronym / sponsor ID
- GWang007
- Conditions
- Etomidate is Mixed With Propofol
- Keywords
- propofol, etomidate, General anesthesia, mixture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guolin WangUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 26 Feb 2019 (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 purpose of this study was to investigate the effects of different proportions of etomidate/propofol mixture and propofol alone intravenous anesthesia on intraoperative and postoperative physiological indicators and complications, and to find out the optimal use ratio of E/P mixture.
Detailed description
Propofol is one of the most commonly used intravenous anesthesia drugs clinically, the pharmacokinetic characteristics makes it very suitable for total intravenous anesthesia( TIVA), etomidate belongs to intravenous anesthesia with propofol, is a derivative of the imidazoles, its calm performance is strong, work quickly, no obvious respiratory depression, had little effects on the cardiovascular system, which, therefore, to protect the cardiovascular, maintain hemodynamic stability has a certain advantage. Our previous project showed that propofol and etomidate combined application can maintain stable hemodynamics in patients with better, reduce the occurrence of adverse reactions, can be used within 3 h of surgery anesthesia.The purpose of this study is to use propofol or etomidate/propofol mixture in combination with BIS monitoring to perform general anesthesia maintenance for patients, in order to ensure the appropriate depth of anesthesia, better maintain the hemodynamic stability of patients, reduce adverse reactions, and find the appropriate E/P mixture of the best proportion and dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Propofol 20 MG/MLPropofol 20 mg/ml, recommended anesthesia induction dose of 0.1~0.125 ml/kg, anesthesia maintenance pump speed of 0.2~0.5ml/kg/h. keep bispectral index within 40 # 60 |
| GroupB | Active comparator | Drug: Propofol 20 mg/ml , etomidate 2 mg/mlEP1:3, that is, 10ml etomidate was mixed with 30ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml. |
| Group C | Active comparator | Drug: Propofol 20 mg/ml , etomidate 2 mg/mlEP1:1, that is, 20ml etomidate was mixed with 20ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml. |
| Group D | Active comparator | Drug: Propofol 20 mg/ml , etomidate 2 mg/mlEP3:1, that is, 30ml etomidate was mixed with 10ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing elective general anesthesia surgery in 3h;
- American Society of Anesthesiologists gradesⅠ~III;
- Aged 18 to 65 years, Body Mass Index 18.5 ~ 29.9kg / m2;
- Hemoglobin 100 ~ 125g / L.
- In line with the ethics, the patients volunteered to take the test and signed the informed consent
Key exclusion criteria (11 listed)
- Identify or suspect abuse or chronic use of narcotic sedatives and analgesics;
- Heart, or liver, or lung, or kidney dysfunction;
- Body mass index> 30kg / m2; or <18.5kg / m2
- Speech, hearing or mental disorders;
- severe diabetes, hyperkalemia ;
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 |
|---|---|---|
| Propofol 20 MG/MLPump propofol to keep bispectral index within 40 # 60 | Drug | Group A |
| Propofol 20 mg/ml , etomidate 2 mg/mlPropofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60. | Drug | Group C, Group D, GroupB |
Primary outcome
blood pressure
Time frame: intraoperative
the blood pressure is recorded (mmHg)
heart rate
Time frame: intraoperative
the heart rate is recorded(bpm)
1 secondary outcome
Perioperative complications
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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.
Guolin Wang, MD.PHD study director
Tainjin Medical University General Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol 20 MG/ML and Propofol 20 mg/ml , etomidate 2 mg/ml in people with Etomidate is Mixed With Propofol, run by Guolin Wang 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 5 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: status not confirmed, as of the sponsor's last update on 26 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zicheng Wang, MM (13821112922, 527640484@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: intraoperative). The study lists 2 primary outcomes in all. 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 26 Feb 2019.