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HemodynamicsPhase 4NCT02202239

Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients

A Phase 4 study testing midazolam, Penehyclidine Hydrochloride Injection and Etomidate in people with Hemodynamics and Oxidative Stress, run by Zhujiang Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hemodynamics, Oxidative Stress, Anesthesia
What is being tested?
midazolam, Penehyclidine Hydrochloride Injection and Etomidate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Sep 2014to Aug 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 65 years;
  • Diabetic patients preparing for elective surgery;
  • Body mass index is between 16 and 30 kg/m2;
  • Blood glucose is under 8.3 mmol/kg by oral antidiabetic agents or diet control;
  • American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ;
  • Expected operation duration is between 2 and 8 h;
  • Signed informed consent form.

Who cannot join

  • Severe cardiac, cerebral, liver, kidney, lung, endocrine disease or infectious disease;
  • Chemotherapy or immunotherapy before the surgery;
  • Allergy to trial drug or other contraindication;
  • Expected or history of difficult airway;
  • Suspected abuse of narcotic analgesia;
  • Diseases of neuromuscular system;
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  • Mentally unstable or has a mental illness;
  • Trend of malignant hyperthermia;
  • Pregnant or breast-feeding women;
  • Attendance of other trial past 30 days.

About this study

To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic patients.

Being tested
midazolam, Penehyclidine Hydrochloride Injection, Etomidate, Propofol, Fentanyl

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • midazolamDrug

    Also called Li Yue Xi

    Before induction, midazolam 0.05mg/kg will be injected intravenously.

  • Penehyclidine Hydrochloride InjectionDrug

    Also called Chang Tuo Ning

    Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.

  • EtomidateDrug

    Also called Fu Er Li

    Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.

  • PropofolDrug

    Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.

  • FentanylDrug

    During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.

  • Cisatracurium BesilateDrug

    Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.

    During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation.

  • RemifentanilDrug

    Remifentanil will be injected continuously during maintenance of anesthesia.

  • SevofluraneDrug

    Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.

Study groups in NCT02202239
Study groupRoleWhat they receive
Group EExperimentalEtomidate was used in both induction and maintenance of anesthesia.
Receives: Drug: midazolam; Drug: Penehyclidine Hydrochloride Injection; Drug: Etomidate; Drug: Fentanyl; Drug: Cisatracurium Besilate; Drug: Remifentanil; Drug: Sevoflurane
Group PActive comparatorPropofol was used in both induction and maintenance of anesthesia.
Receives: Drug: midazolam; Drug: Propofol; Drug: Fentanyl; Drug: Cisatracurium Besilate; Drug: Remifentanil; Drug: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean arterial pressure

    Mean arterial pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  2. Central venous pressure

    Central venous pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  3. Heart rate

    Heart rate will be recorded 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  4. Respiratory rate

    Respiratory rate will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  5. Oxygen saturation

    Oxygen saturation will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  6. Blood glucose

    Blood glucose will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5).

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  7. Insulin

    Insulin will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5).

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

Secondary outcomes (3)

  1. Super oxide dismutase

    2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before super oxide dismutase was measured.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  2. Glutathione

    2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before glutathione was measured.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

  3. Xanthine oxidase

    2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before xanthine oxidase dismutase was measured.

    Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

    Measured: from 10 minutes before induction to 1 h after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2015 (estimated)
  4. Study completionAug 2015 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02202239
Sponsor's protocol ID
20140723
Status last verified
Jul 2014
First submitted
24 Jul 2014
Last updated
28 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing midazolam, Penehyclidine Hydrochloride Injection and Etomidate in people with Hemodynamics and Oxidative Stress, run by Zhujiang 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 7 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 28 Jul 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?

Mean arterial pressure (time frame: from 10 minutes before induction to 1 h after the surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02202239.

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 Jul 2014.

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