Induced AbortionPhase 4NCT02208596
The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial
A Phase 4 study testing pentazocine, propofol and Etomidate in people with Induced Abortion and Anesthesia, run by Third Affiliated Hospital of Zhengzhou University.
Trial summary
To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Induced Abortion, Anesthesia
- What is being tested?
- pentazocine, propofol and Etomidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Feb 2015
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20 and 35 years
- American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
- Singleton pregnancy and the gestational period is 6 to 8 weeks
- Expected operation duration is within 60 minutes
- The body weight should be within 15% around the standard weight
- Signed informed consent form
Who cannot join
- Serious cardiac, cerebral, liver, kidney, lung, endocrine disease
- Upper respiratory infections within 4 weeks
- Long use of hormone or history of adrenal suppression
- History of use of glucocorticoids, aprotinin or immunosuppressant
- Manifestation of immunodeficiency
- History of use of sedatives or opiates
Show all 10Show fewer
- Needs of Neuromuscular blocker (except intubation)
- Allergy to trial drug or other contraindication
- Pregnant or breast-feeding women
- Attended other trial past 30 days
About this study
To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial.
- Conditions
- Induced Abortion, Anesthesia
- Being tested
- pentazocine, propofol, Etomidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentazocineDrug
Every patient enrolled in the study will be given 15 mg pentazocine before induction.
propofolDrug
EtomidateDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure. Receives: Drug: pentazocine; Drug: propofol; Drug: Etomidate |
| Group B | Experimental | In group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure. Receives: Drug: pentazocine; Drug: propofol; Drug: Etomidate |
| Group C | Experimental | In group C, propofol (1%) will be injected continuously until the eyelash reflex disappears. During the operation, supplementary propofol will be administered if the patient has spontaneous movement that hampered the conduct of the procedure. Receives: Drug: pentazocine; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
Measured: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Blood pressure
Blood pressure will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
Measured: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Pulse oxygen saturation
Pulse oxygen saturation will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
Measured: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Secondary outcomes (6)
Efficacy of anesthesia
The following point-in-time will be recorded to calculated the period from the injection of propofol or mixture of propofol and etomidate: disappearance of eyelash reflex, injection of supplementary propofol or mixture of propofol and etomidate, awaking, obeying commands, discharge. Anesthesia time was defined as the period from disappearance of eyelash reflex to awaking.
Measured: from baseline to discharge from the hospital, expected to no more than 1 hour
Dose of propofol or mixture of propofol and etomidate
Measured: from the injection of propofol or mixture of propofol and etomidate to the last supplement of hypnotic agents, expected to be no more than 5 min
Use of specific medications
Measured: from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour
Aldrete score
Measured: 10 min after the opration
Verbal rating scales of uterine contraction
Verbal rating scales of uterine contraction should be recorded at 5 min, 15 min after the operation and before discharge from the hospital
Measured: from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour
Satisfaction degree of the patient, the surgeon and the anesthetist
Satisfaction degree will be rated as excellent, good and poor based on a scale of 1 to 10. Excellent is 8 to 10, good is 5 to 7 and poor is 1 to 4.
Measured: 10 min before discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced AbortionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208596
- Sponsor's protocol ID
- 20140729
- Status last verified
- Aug 2014
- First submitted
- 1 Aug 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02208596
- Acronym / sponsor ID
- 20140729
- Conditions
- Induced Abortion, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 5 Aug 2014 (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.
To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: pentazocine, Drug: propofol, Drug: EtomidateIn group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure. |
| Group B | Experimental | Drug: pentazocine, Drug: propofol, Drug: EtomidateIn group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure. |
| Group C | Experimental | Drug: pentazocine, Drug: propofolIn group C, propofol (1%) will be injected continuously until the eyelash reflex disappears. During the operation, supplementary propofol will be administered if the patient has spontaneous movement that hampered the conduct of the procedure. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 20 and 35 years
- American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
- Singleton pregnancy and the gestational period is 6 to 8 weeks
- Expected operation duration is within 60 minutes
- The body weight should be within 15% around the standard weight
Key exclusion criteria (10 listed)
- Serious cardiac, cerebral, liver, kidney, lung, endocrine disease
- Upper respiratory infections within 4 weeks
- Long use of hormone or history of adrenal suppression
- History of use of glucocorticoids, aprotinin or immunosuppressant
- Manifestation of immunodeficiency
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 |
|---|---|---|
| pentazocineEvery patient enrolled in the study will be given 15 mg pentazocine before induction. | Drug | Group A, Group B, Group C |
| propofol | Drug | Group A, Group B, Group C |
| Etomidate | Drug | Group A, Group B |
Primary outcome
Heart rate
Time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Heart rate will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
Blood pressure
Time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Blood pressure will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
Pulse oxygen saturation
Time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Pulse oxygen saturation will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
6 secondary outcomes
Efficacy of anesthesia
Time frame: from baseline to discharge from the hospital, expected to no more than 1 hour
Dose of propofol or mixture of propofol and etomidate
Time frame: from the injection of propofol or mixture of propofol and etomidate to the last supplement of hypnotic agents, expected to be no more than 5 min
Use of specific medications
Time frame: from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour
Aldrete score
Time frame: 10 min after the opration
Verbal rating scales of uterine contraction
Time frame: from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour
Satisfaction degree of the patient, the surgeon and the anesthetist
Time frame: 10 min before discharge from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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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 Phase 4 study testing pentazocine, propofol and Etomidate in people with Induced Abortion and Anesthesia, run by Third Affiliated Hospital of Zhengzhou 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 6 inclusion and 10 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 5 Aug 2014. 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.
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?
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?
Heart rate (time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection). The study lists 3 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 Aug 2014.