General AnesthesiaPhase 4NCT05223907
Safety and Efficacy of Maintenance of Etomidate in General Anesthesia
A Phase 4 study testing Etomidate and Propofol in people with General Anesthesia, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
This study was designed to use etomidate combined with sevoflurane intravenously to maintain anesthesia process under the monitoring of BIS. Propofol was used as the controls. Blood pressure and heart rate were recorded during operation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Etomidate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤age≤65;
- Types of surgery: laparoscopic gynecological surgery, laparoscopic gastrointestinal surgery, thoracoscopic radical lung cancer surgery;
- 1 h ≤ operation time ≤ 3 h;
- ASA grade I~III;
- BMI of 18.5~29.9 kg/m2 [BMI= weight (kg)/height (m) 2] (2013 American guidelines for the Management of Overweight and Obesity in Adults);
- In accordance with ethics, the patient voluntarily took the test and signed the informed consent.
Who cannot join
- Cerebral vascular accident, such as stroke, transient ischemic attack (TIA), etc. within 3 months;
- Severe abnormal liver and kidney function (severe abnormal liver function: ALT, AST, ALP, total bilirubin, one of which is more than 2 times the upper limit of normal value. Severe renal dysfunction: creatinine > 2 times upper normal);
- Patients with diabetic complications (diabetic ketoacidosis, hyperotonic coma, various infections, macrovascular disease, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);
- Unstable angina pectoris or myocardial infarction occurred within 3 months;
- Preoperative blood pressure ≥160/100 mmHg ( ≥ Grade 2 hypertension, 2020 ISH Hypertension Guidelines);
- Identified/suspected abuse or long-term use of narcotic sedatives and analgesics; •Taking hormones or other immunosuppressive agents for more than 10 days within half a year, or having a history of adrenocortical suppression or immune system diseases;
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- Hypothyroidism;
- Patients with a history of asthma;
- Those who were reoperated within 3 months;
- Having contraindications or allergies to test drugs and other narcotic drugs;
- Patients enrolled in other studies within 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Maintenance of Etomidate Combined With Sevoflurane in General Anesthesia: a Multi-center Randomized Controlled Study
This study was designed to use etomidate combined with sevoflurane intravenously to maintain anesthesia process under the monitoring of BIS. Propofol was used as the controls. Blood pressure and heart rate were recorded during operation. The VAS pain score was observed after surgery.To investigate whether this program can better maintain intraoperative hemodynamic stability, improve the quality of recovery, and reduce the incidence of postoperative adverse reactions.
- Conditions
- General Anesthesia
- Being tested
- Etomidate, Propofol
- Keywords
- etomidate, propofol, anesthesia maintenance, sevoflurane, anesthesia quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Also called Etomidate Injectable Emulsion, Yituomizhi, H20020511, WS-400(X-338)-2002-2015Z,YT211101
Etomidate will be used for general anesthesia
PropofolDrug
Also called Diprivan, JX20060102，H20080473，RW981
Propofol will be used for general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Etomidate | Experimental | Etomidate will be used for general anesthesia Receives: Drug: Etomidate |
| Group Propofol | Experimental | Propofol will be used for general anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intraoperative hypertension and hypotension
Investigators will record the rate of hypertension and hypotension of participants during intraoperative period
Measured: From the beginning to the end of surgery
Ricker sedation-agitation score after surgery
Investigators will record the Ricker sedation-agitation score of participants during recovery period after general anestesia
Measured: 1 day (The period during patients wake up after surgery and general anesthesia in the recovery room.)
Secondary outcomes (2)
Postoperative pain scores measured by VAS score.
Postoperative pain scores of participants will be assessed by using VAS score (0= no pain, 10= worse pain imaginable)
Measured: One-three days after surgery.
The incidence of PONV
The incidence of postoperative nausea and vomiting of participants will be recorded
Measured: One-three days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 May 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiaqiang Zhang, PHD, Study chair, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223907
- Sponsor's protocol ID
- ytmz
- Status last verified
- Jun 2024
- First submitted
- 28 Dec 2021
- Last updated
- 5 Jun 2024
- 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Maintenance of Etomidate Combined With Sevoflurane in General Anesthesia: a Multi-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05223907
- Acronym / sponsor ID
- ytmz
- Conditions
- General Anesthesia
- Keywords
- etomidate, propofol, anesthesia maintenance, sevoflurane, anesthesia quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Feb 2022 (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.
This study was designed to use etomidate combined with sevoflurane intravenously to maintain anesthesia process under the monitoring of BIS. Propofol was used as the controls. Blood pressure and heart rate were recorded during operation. The VAS pain score was observed after surgery.To investigate whether this program can better maintain intraoperative hemodynamic stability, improve the quality of recovery, and reduce the incidence of postoperative adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Etomidate | Experimental | Drug: EtomidateEtomidate will be used for general anesthesia |
| Group Propofol | Experimental | Drug: PropofolPropofol will be used for general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 ≤age≤65;
- Types of surgery: laparoscopic gynecological surgery, laparoscopic gastrointestinal surgery, thoracoscopic radical lung cancer surgery;
- 1 h ≤ operation time ≤ 3 h;
- ASA grade I~III;
- BMI of 18.5~29.9 kg/m2 [BMI= weight (kg)/height (m) 2] (2013 American guidelines for the Management of Overweight and Obesity in Adults);
Key exclusion criteria (11 listed)
- Cerebral vascular accident, such as stroke, transient ischemic attack (TIA), etc. within 3 months;
- Severe abnormal liver and kidney function (severe abnormal liver function: ALT, AST, ALP, total bilirubin, one of which is more than 2 times the upper limit of normal value. Severe renal dysfunction: creatinine > 2 times upper normal);
- Patients with diabetic complications (diabetic ketoacidosis, hyperotonic coma, various infections, macrovascular disease, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);
- Unstable angina pectoris or myocardial infarction occurred within 3 months;
- Preoperative blood pressure ≥160/100 mmHg ( ≥ Grade 2 hypertension, 2020 ISH Hypertension Guidelines);
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 |
|---|---|---|
| EtomidateAlso: Etomidate Injectable Emulsion, Yituomizhi, H20020511, WS-400(X-338)-2002-2015Z,YT211101Etomidate will be used for general anesthesia | Drug | Group Etomidate |
| PropofolAlso: Diprivan, JX20060102，H20080473，RW981Propofol will be used for general anesthesia | Drug | Group Propofol |
Primary outcome
Rate of intraoperative hypertension and hypotension
Time frame: From the beginning to the end of surgery
Investigators will record the rate of hypertension and hypotension of participants during intraoperative period
Ricker sedation-agitation score after surgery
Time frame: 1 day (The period during patients wake up after surgery and general anesthesia in the recovery room.)
Investigators will record the Ricker sedation-agitation score of participants during recovery period after general anestesia
2 secondary outcomes
Postoperative pain scores measured by VAS score.
Time frame: One-three days after surgery.
The incidence of PONV
Time frame: One-three days after surgery.
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 5 Jun 2024.
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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.
Jiaqiang Zhang, PHD study chair
Henan Provincial People's Hospital
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 Etomidate and Propofol in people with General Anesthesia, run by Henan Provincial People's Hospital 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 6 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: finished, as of the sponsor's last update on 5 Jun 2024. 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.
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?
Rate of intraoperative hypertension and hypotension (time frame: From the beginning to the end of surgery). 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 5 Jun 2024.