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.
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
- Conditions the study is for
- C.Delivery; Surgery (Previous), Gynecological
- 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
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 group | Role | What they receive |
|---|---|---|
| the target propofol concentration | Experimental | 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.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.
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.
- First posted18 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Delivery; Surgery (Previous), GynecologicalStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tingting Wang, Fudan University
- Investigators
- Shaoqiang Huang, Study director, Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effective Effect-Site Propofol Concentration for Induction and Intubation for Schnider Model in Parturients
- ClinicalTrials.gov ID
- NCT02554175
- Acronym / sponsor ID
- TTWang
- Keywords
- Propofol, Schnider model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Sep 2015 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the target propofol concentration | Experimental | Drug: Propofolpatients 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Thirty-six women undergoing elective cesarean section under general anesthesia were enrolled in this prospective observational study.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PropofolPropofol was administered to achieve target propofol Ce | Drug | the target propofol concentration |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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.
Shen Sun contact
Shaoqiang Huang study director
Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
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.