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C.Delivery; Surgery (Previous), GynecologicalNCT02554175

The Effective Effect-Site Propofol Concentration for Induction and Intubation for Schnider Model in Parturients

A study testing Propofol in people with C.Delivery; Surgery (Previous), Gynecological, run by Fudan University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this study was to determine the target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
Oct 2015to Dec 2017
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Thirty-six women undergoing elective cesarean section under general anesthesia were enrolled in this prospective observational study.

Who cannot join

  • Diabetes controlled by insulin
  • Preeclampsia
  • Heart diseases
  • History of taking drugs potentially affecting cardiovascular system.
  • Patients fasted for at least 8 hours before surgery and no premedication was given

Trial locations and contacts

No sites are listed yet.

Shen Sun contact

sunshen1980@126.com

About this study

The aim of this study was to determine the target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients. In addition, investigators wanted to define the hemodynamic adverse effects associated with these propofol target concentrations.

Read the detailed description

The temperature was maintained at 22˚ C in the operating room. Patients were placed supine with 15°left lateral tilt achieved using a wedge under the right buttock. Electrocardiograph (ECG), pulse oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were monitored by one anesthesiologist (S/5 Anesthesia Monitor, GE Healthcare, Helsinki, Finland), and Bispectral Index (BIS) values (A2000 BIS® XP monitor, version 3.2; Aspect Medical Systems Inc., Newton, MA) were obtained and recorded. The BIS smoothing time period was set at 15 seconds. The mean values of the above-mentioned parameters were recorded at 3-min intervals for three consecutive times to determine baseline values. Peripheral vein catheterization on the right hand was then performed but no prehydration was given. A fixed volume of 500 mL hydroxyethyl starch solution was infused at the rate of 0.2 ml.kg-1.min-1, then Lactated Ringer's solution was infused at the same rate until the end of surgery.

Using a computer-generated random-number sequence, patients were allocated to 1 of 6 groups of predefined propofol target Ce for induction, namely, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 µg.mL-1. General anesthesia was induced with fentanyl 3 µg.kg-1. Propofol was administered by the TCI device to achieve the predetermined target propofol Ce. Loss of consciousness was defined by the disappearance of the eyelash reflex that was assessed every 5 seconds after patients spontaneously closed their eyes. After loss of consciousness, succinylcholine 1.5 mg.kg-1 was administered and tracheal intubation was performed 1 minutes later only if the BIS value was <60 and target propofol Ce had been reached. After intubation, patients were connected to mechanical ventilation adjusted to obtain an end-tidal CO2 of 30 to 35 mm Hg and the propofol target concentration was reduced to 3µg.mL-1. Anesthesiologists performing loss of consciousness assessment and intubation were blinded to the target propofol Ce. SpO2, SBP, DBP, MAP and HR were recorded once a minute for 10 min until 5 minutes after tracheal intubation when the study finished.

Being tested
Propofol
Keywords
Propofol, Schnider model

What participants receive

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

  • PropofolDrug

    Propofol was administered to achieve target propofol Ce

Study groups in NCT02554175
Study groupRoleWhat they receive
the target propofol concentrationExperimentalpatients were allocated to 1 of 6 groups of predefined propofol target Ce for induction, namely, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 µg.mL-1.Propofol was administered to achieve target propofol Ce.
Receives: Drug: Propofol

What is being measured

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

  1. target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients

    Measured: up to 24 months

Timeline

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

  1. First posted18 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionAug 2017 (estimated)
  4. Study completionDec 2017 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554175
Sponsor's protocol ID
TTWang
Status last verified
Sep 2015
First submitted
26 Aug 2015
Last updated
18 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Propofol in people with C.Delivery; Surgery (Previous), Gynecological, run by Fudan 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 1 inclusion and 5 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 18 Sep 2015. 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?

Contact Shen Sun (sunshen1980@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients (time frame: up to 24 months). 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 18 Sep 2015.

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