HysteroscopyPhase 4NCT02147678
A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients
A Phase 4 study testing Etomidate, Propofol and Remifentanil in people with Hysteroscopy and Hemodynamics, run by Shaanxi Provincial People's Hospital.
Trial summary
To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hysteroscopy, Hemodynamics, Sedation
- What is being tested?
- Etomidate, Propofol and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 60 and 80 years
- Selective hysteroscopic operation
- American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
- Signed informed consent form
- Expected operation duration is within 60 minutes
Who cannot join
- Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis
- Long use of hormone or history of adrenal suppression
- Allergy to trial drug or other contraindication
- History or expected difficult airway
- Identified, suspected abuse or long use of narcotic analgesia
- Neuromuscular diseases
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- Mentally unstable or has a mental illness
- Dysfunction of communication
- Trend of malignant hyperthermia
- Pregnant or breast-feeding women
- Attended other trial past 30 days;
Trial locations and contacts
No sites are listed yet.
About this study
To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients
- Conditions
- Hysteroscopy, Hemodynamics, Sedation
- Being tested
- Etomidate, Propofol, Remifentanil, Anesthesia induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Also called Fu Er Li
PropofolDrug
RemifentanilDrug
During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 μg/kg/min.
Anesthesia inductionDrug
For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Experimental | Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10~15 μg/kg/min and 0.2~0.4 μg/kg/min, respectively. Receives: Drug: Etomidate; Drug: Remifentanil; Drug: Anesthesia induction |
| Group P | Experimental | Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50~75 μg/kg/min and 0.2~0.4 μg/kg/min, respectively. Receives: Drug: Propofol; Drug: Remifentanil; Drug: Anesthesia induction |
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 after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Measured: Immediately after the entrance to the operating room until until 60 minutes after the operation
Mean arterial pressure
Mean arterial pressure will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Measured: Immediately after the entrance to the operating room until until 60 minutes after the operation
Pulse oxygen saturation
Pulse oxygen saturation will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Measured: Immediately after the entrance to the operating room until until 60 minutes after the operation
Respiratory rate
Respiratory rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Measured: Immediately after the entrance to the operating room until until 60 minutes after the operation
Narcotrend index
Narcotrend index will be recorded immediately after the entance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Measured: Immediately after the entrance to the operating room until until 60 minutes after the operation
Secondary outcomes (4)
Cerebral injury parameters
2 ml blood will be collected immediately after the entrance to the operating room and 60 min after the operation, then SB-100 protein and neuron-specific enolase will be tested by enzyme-linked immunosorbent assay.
Measured: Immediately after the entrance to the operating room until until 60 minutes after the operation
Length of stay
Measured: from the date of admission to the day of discharge, expected to 3 days
Score of Minimum Mental State Examination
Score of Minimum Mental State Examination will be examined in preoperative visit, 10 minutes, 45 minutes after the operation
Measured: 1 day before the operation to 45 minutes after the operation
Verbal Fluency test
Verbal Fluency test will be examined in preoperative visit and 60 minutes after the operation
Measured: 1 day before the operation to 60 minutes after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startDec 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 HysteroscopyStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenying Song, Shaanxi Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147678
- Sponsor's protocol ID
- 20140522
- Status last verified
- May 2014
- First submitted
- 22 May 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients
- ClinicalTrials.gov ID
- NCT02147678
- Acronym / sponsor ID
- 20140522
- Conditions
- Hysteroscopy, Hemodynamics, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shaanxi Provincial People's HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 28 May 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 compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | Experimental | Drug: Etomidate, Drug: Remifentanil, Drug: Anesthesia inductionEtomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10~15 μg/kg/min and 0.2~0.4 μg/kg/min, respectively. |
| Group P | Experimental | Drug: Propofol, Drug: Remifentanil, Drug: Anesthesia inductionPropofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50~75 μg/kg/min and 0.2~0.4 μg/kg/min, respectively. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 60 and 80 years
- Selective hysteroscopic operation
- American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
- Signed informed consent form
- Expected operation duration is within 60 minutes
Key exclusion criteria (11 listed)
- Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis
- Long use of hormone or history of adrenal suppression
- Allergy to trial drug or other contraindication
- History or expected difficult airway
- Identified, suspected abuse or long use of narcotic analgesia
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: Fu Er Li | Drug | Group E |
| Propofol | Drug | Group P |
| RemifentanilDuring anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 μg/kg/min. | Drug | Group E, Group P |
| Anesthesia inductionFor all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg. | Drug | Group E, Group P |
Primary outcome
Heart rate
Time frame: Immediately after the entrance to the operating room until until 60 minutes after the operation
heart rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Mean arterial pressure
Time frame: Immediately after the entrance to the operating room until until 60 minutes after the operation
Mean arterial pressure will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Pulse oxygen saturation
Time frame: Immediately after the entrance to the operating room until until 60 minutes after the operation
Pulse oxygen saturation will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Respiratory rate
Time frame: Immediately after the entrance to the operating room until until 60 minutes after the operation
Respiratory rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Narcotrend index
Time frame: Immediately after the entrance to the operating room until until 60 minutes after the operation
Narcotrend index will be recorded immediately after the entance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
4 secondary outcomes
Cerebral injury parameters
Time frame: Immediately after the entrance to the operating room until until 60 minutes after the operation
Length of stay
Time frame: from the date of admission to the day of discharge, expected to 3 days
Score of Minimum Mental State Examination
Time frame: 1 day before the operation to 45 minutes after the operation
Verbal Fluency test
Time frame: 1 day before the operation to 60 minutes after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etomidate, Propofol and Remifentanil in people with Hysteroscopy and Hemodynamics, run by Shaanxi Provincial People's 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 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 28 May 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?
Contact Wenying Song (+86-13609245447, swysong2010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Immediately after the entrance to the operating room until until 60 minutes after the operation). The study lists 5 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 28 May 2014.