Intraoperative AwarenessNCT03508102
Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
A study testing remifentanil in people with Intraoperative Awareness, run by West China Second University Hospital.
Trial summary
Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intraoperative Awareness
- What is being tested?
- remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia
Who cannot join
- multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication
About this study
Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
Read the detailed description
Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The investgators assessed the average value of BIS at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. The investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood gas analysis.
- Conditions
- Intraoperative Awareness
- Being tested
- remifentanil
- Keywords
- remifentanil, bispectral index, Caesarean delivery, general anesthesia
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
Also called saline
the effects of remifentanil on the average value of BIS at the time period of before induction , induction , intubation , skin incision, peritoneum incision, uterine incision, and delivery
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil 1 μg kg-1 (R1) | Experimental | Received remifentanil 1μg/kg when induction of general anesthesia Receives: Drug: remifentanil |
| Remifentanil 0.5 μg kg-1 (R0.5), | Experimental | Received remifentanil 0.5μg/kg when induction of general anesthesia Receives: Drug: remifentanil |
| saline (control) | No intervention | Injected the equal volume normal saline when induction of general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
the average value of BIS at the time period of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
Measured: the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
Secondary outcomes (1)
incidence of intraoperative awareness
the maternal incidence of intraoperative awareness
Measured: one day and one week after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startAug 2015
- Primary completionSep 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative AwarenessStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Zhu, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508102
- Sponsor's protocol ID
- 2015001
- Status last verified
- Apr 2018
- First submitted
- 29 Nov 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT03508102
- Acronym / sponsor ID
- 2015001
- Conditions
- Intraoperative Awareness
- Keywords
- remifentanil, bispectral index, Caesarean delivery, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Apr 2018 (actual)
- 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.
Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
Detailed description
Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The investgators assessed the average value of BIS at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. The investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood gas analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remifentanil 1 μg kg-1 (R1) | Experimental | Drug: remifentanilReceived remifentanil 1μg/kg when induction of general anesthesia |
| Remifentanil 0.5 μg kg-1 (R0.5), | Experimental | Drug: remifentanilReceived remifentanil 0.5μg/kg when induction of general anesthesia |
| saline (control) | No intervention | –Injected the equal volume normal saline when induction of general anesthesia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia
Key exclusion criteria (1 listed)
- multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication
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 |
|---|---|---|
| remifentanilAlso: salinethe effects of remifentanil on the average value of BIS at the time period of before induction , induction , intubation , skin incision, peritoneum incision, uterine incision, and delivery | Drug | Remifentanil 0.5 μg kg-1 (R0.5),, Remifentanil 1 μg kg-1 (R1) |
Primary outcome
the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
Time frame: the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
the average value of BIS at the time period of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
1 secondary outcome
incidence of intraoperative awareness
Time frame: one day and one week after delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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 study testing remifentanil in people with Intraoperative Awareness, run by West China Second University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the effects of remifentanil on the bispectral index (BIS) in the interval before delivery. (time frame: the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery). 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 25 Apr 2018.