Etomidate Induced DoseNCT05520645
Etomidate Induction in Hysteroscopic Surgery
A study testing etomidate and propofol in people with Etomidate Induced Dose and Hysteroscopic Surgery, run by Peking University Third Hospital.
Trial summary
This study intends to study the optimal dose induced by etomidate in outpatients undergoing painless hysteroscopic surgery. At present, the dosage in the user manual is 0.1-0.3mg/kg. In clinical use, it is found that 0.1mg/kg often fails to achieve sedative effect, and 0.3mg/kg is prone to muscle twitching. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Etomidate Induced Dose, Hysteroscopic Surgery
- What is being tested?
- etomidate and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2022to 30 Dec 2023
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients to undergo hysteroscopic surgery
Who cannot join
- Hemo-dynamically unstable patients Allergic to egg protein Patients with epilepsy
About this study
Official title: Randomized Controlled Study of Etomidate Induction in Hysteroscopic Surgery
This study intends to study the optimal dose induced by etomidate in outpatients undergoing painless hysteroscopic surgery. At present, the dosage in the user manual is 0.1-0.3mg/kg. In clinical use, it is found that 0.1mg/kg often fails to achieve sedative effect, and 0.3mg/kg is prone to muscle twitching. Therefore, three groups of doses of 0.15mg/kg, 0.2mg/kg and 0.25mg/kg are set. It is hoped that this study will provide a basis for clinical evaluation of etomidate in anesthesia induction of hysteroscopic surgery.
- Conditions
- Etomidate Induced Dose, Hysteroscopic Surgery
- Being tested
- etomidate, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etomidateDrug
use etomidate for anesthesia induction in hysteroscopic surgery
propofolDrug
use propofol for anesthesia induction in hysteroscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Eto 0.15mg/kg | Experimental | Etomidate 0.15mg/kg for anesthesia induction Receives: Drug: etomidate |
| Eto 0.2mg/kg | Experimental | Etomidate 0.2mg/kg for anesthesia induction Receives: Drug: etomidate |
| Eto 0.25mg/kg | Experimental | Etomidate 0.25mg/kg for anesthesia induction Receives: Drug: etomidate |
| Propofol 2mg/kg | Active comparator | propofol 2mg/kg for anesthesia induction Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Mean value of Mean Arterial Pressures
Measured: Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes
Heart rate per minute
Mean of Heart rate per minute at above mentioned time intervals was measured and any study drug causing bradycardia
Measured: Change in Heart rate per minute from baseline value every five minutes for 30 minutes
Secondary outcomes (3)
Myoclonic movements
% of cases with Myoclonic movements
Measured: 60 seconds after injection of study drug
Post Operative Nausea and Vomiting
% of cases with any treatment for Post Operative Nausea and Vomiting
Measured: Throughout entire study estimated to take 1 month to complete
any oxygen saturation event below 85% by pulse oximetry
% of cases with any oxygen saturation event below 85% by pulse oximetry
Measured: Throughout entire study estimated to take 1 month to complet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start25 Aug 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Etomidate Induced DoseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520645
- Sponsor's protocol ID
- 89476
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Etomidate Induction in Hysteroscopic Surgery
- ClinicalTrials.gov ID
- NCT05520645
- Acronym / sponsor ID
- 89476
- Conditions
- Etomidate Induced Dose, Hysteroscopic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 Aug 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 30 Aug 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 intends to study the optimal dose induced by etomidate in outpatients undergoing painless hysteroscopic surgery. At present, the dosage in the user manual is 0.1-0.3mg/kg. In clinical use, it is found that 0.1mg/kg often fails to achieve sedative effect, and 0.3mg/kg is prone to muscle twitching. Therefore, three groups of doses of 0.15mg/kg, 0.2mg/kg and 0.25mg/kg are set. It is hoped that this study will provide a basis for clinical evaluation of etomidate in anesthesia induction of hysteroscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eto 0.15mg/kg | Experimental | Drug: etomidateEtomidate 0.15mg/kg for anesthesia induction |
| Eto 0.2mg/kg | Experimental | Drug: etomidateEtomidate 0.2mg/kg for anesthesia induction |
| Eto 0.25mg/kg | Experimental | Drug: etomidateEtomidate 0.25mg/kg for anesthesia induction |
| Propofol 2mg/kg | Active comparator | Drug: propofolpropofol 2mg/kg for anesthesia induction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients to undergo hysteroscopic surgery
Key exclusion criteria (1 listed)
- Hemo-dynamically unstable patients Allergic to egg protein Patients with epilepsy
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 |
|---|---|---|
| etomidateuse etomidate for anesthesia induction in hysteroscopic surgery | Drug | Eto 0.15mg/kg, Eto 0.25mg/kg, Eto 0.2mg/kg |
| propofoluse propofol for anesthesia induction in hysteroscopic surgery | Drug | Propofol 2mg/kg |
Primary outcome
Mean Arterial Pressure
Time frame: Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes
Mean value of Mean Arterial Pressures
Heart rate per minute
Time frame: Change in Heart rate per minute from baseline value every five minutes for 30 minutes
Mean of Heart rate per minute at above mentioned time intervals was measured and any study drug causing bradycardia
3 secondary outcomes
Myoclonic movements
Time frame: 60 seconds after injection of study drug
Post Operative Nausea and Vomiting
Time frame: Throughout entire study estimated to take 1 month to complete
any oxygen saturation event below 85% by pulse oximetry
Time frame: Throughout entire study estimated to take 1 month to complet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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 etomidate and propofol in people with Etomidate Induced Dose and Hysteroscopic Surgery, run by Peking University Third Hospital.
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 1 inclusion and 1 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 30 Aug 2022. 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. 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?
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?
Mean Arterial Pressure (time frame: Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes). 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 30 Aug 2022.