Pre-EclampsiaPhase 4NCT00567957
Remifentanil for General Anesthesia in Preeclamptics
A Phase 4 study testing Remifentanil and Saline in people with Pre-Eclampsia and Hypertension, Pregnancy-Induced, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Pregnancy Complications
- What is being tested?
- Remifentanil and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2008to Dec 2009
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Severe preeclamptic parturients with single fetus pregnancy with contraindication to regional anesthesia
Who cannot join
- Known allergy to study drugs
- Known fetal anomaly and /or gestation week and /or estimated to be nonviable (fetal weight <400 gr, gestational week<24 weeks)
- Known cardiac disease diagnosed prior to pregnancy
- Known drug abuse in the parturient
- Multifetal gestation
- Anticipated difficult airway management (mask ventilation and/or endotracheal intubation).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine Anesthesiology Dept.
Istanbul, Capa, 34390
About this study
Official title: Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients
The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.
Read the detailed description
General anesthesia for cesarean section involves rapid sequence induction with a muscle relaxant and barbiturate followed by endotracheal intubation. Although the use of opioids may blunt haemodynamic responses to endotracheal intubation, they are avoided in pregnant patients due to possible respiratory depressants effects on neonates.Preeclamptic patients response with exaggerated sympathoadrenal reflex to anesthesia induction and intubation. The resulting hypertension and tachycardia may result in cerebrovascular accident, pulmonary edema, arrhythmias, increased myocardial oxygen consumption and fetal hypoxia by uterine vasoconstriction. Several drugs have been used to blunt the hemodynamic disturbances to intubation, but none of them have been implicated for routine use for general anesthesia in preeclamptic patients.
Recently remifentanil has started to be used in general anesthesia of high risk obstetric patients. Remifentanil is a μ-opioid receptor agonist that is metabolized by nonspecific blood and tissue esterase hydrolysis. It has a low distribution volume with a context sensitive half life of 3 minutes. Its elimination half life is 12 minutes even after repeated boli. Previously remifentanil use in pregnant patients with cardiac pathology has been reported with minimal neonatal side effects. A randomized controlled study in normal parturient has shown that remifentanil is transferred through placenta and may cause mild neonatal depression that is easily managed. Umbilical artery and vein remifentanil concentrations has shown that remifentanil is quickly redistributed or metabolized in fetus. Thus, remifentanil may be an appropriate drug for induction and maintenance of general anesthesia in severe preeclamptic patients.
- Being tested
- Remifentanil, Saline
- Keywords
- pre-eclampsia, remifentanil, anesthesia, general, analgesics, opioid, anesthetics, intravenous, Cesarean section, newborn, maternal haemodynamic
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion
SalineDrug
Also called % 0.9 NaCl
same volume iv bolus before induction followed by same volume infusion
| Study group | Role | What they receive |
|---|---|---|
| C | Placebo comparator | Saline starting before induction till entry to abdominal cavity Receives: Drug: Saline |
| R | Active comparator | Remifentanil starting before induction till entry to abdominal cavity Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Induction to post-intubation period
Secondary outcomes (3)
Heart rate
Measured: Induction to delivery
Amount of additional drugs and fluids if required
Measured: Induction to delivery
Evaluation of the newborn
Measured: Within 10 min following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startFeb 2008
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Istanbul 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- Tulay Ozkan Seyhan, Associate Prof, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567957
- Sponsor's protocol ID
- RP01
- Other IDs
- BYP-1833
- Status last verified
- Dec 2007
- First submitted
- 4 Dec 2007
- Last updated
- 5 Dec 2007
- Results posted
- No
Publications
Ngan Kee WD, Khaw KS, Ma KC, Wong AS, Lee BB, Ng FF. Maternal and neonatal effects of remifentanil at induction of general anesthesia for cesarean delivery: a randomized, double-blind, controlled trial. Anesthesiology. 2006 Jan;104(1):14-20. doi: 10.1097/00000542-200601000-00004.
PubMed 16394684
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients
- ClinicalTrials.gov ID
- NCT00567957
- Acronym / sponsor ID
- RP01
- Keywords
- pre-eclampsia, remifentanil, anesthesia, general, analgesics, opioid, anesthetics, intravenous, Cesarean section, newborn, maternal haemodynamic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Study completion
- Dec 2009 (estimated)
- First posted
- 5 Dec 2007 (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 purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.
Detailed description
General anesthesia for cesarean section involves rapid sequence induction with a muscle relaxant and barbiturate followed by endotracheal intubation. Although the use of opioids may blunt haemodynamic responses to endotracheal intubation, they are avoided in pregnant patients due to possible respiratory depressants effects on neonates.Preeclamptic patients response with exaggerated sympathoadrenal reflex to anesthesia induction and intubation. The resulting hypertension and tachycardia may result in cerebrovascular accident, pulmonary edema, arrhythmias, increased myocardial oxygen consumption and fetal hypoxia by uterine vasoconstriction. Several drugs have been used to blunt the hemodynamic disturbances to intubation, but none of them have been implicated for routine use for general anesthesia in preeclamptic patients.
Recently remifentanil has started to be used in general anesthesia of high risk obstetric patients. Remifentanil is a μ-opioid receptor agonist that is metabolized by nonspecific blood and tissue esterase hydrolysis. It has a low distribution volume with a context sensitive half life of 3 minutes. Its elimination half life is 12 minutes even after repeated boli. Previously remifentanil use in pregnant patients with cardiac pathology has been reported with minimal neonatal side effects. A randomized controlled study in normal parturient has shown that remifentanil is transferred through placenta and may cause mild neonatal depression that is easily managed. Umbilical artery and vein remifentanil concentrations has shown that remifentanil is quickly redistributed or metabolized in fetus. Thus, remifentanil may be an appropriate drug for induction and maintenance of general anesthesia in severe preeclamptic patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C | Placebo comparator | Drug: SalineSaline starting before induction till entry to abdominal cavity |
| R | Active comparator | Drug: RemifentanilRemifentanil starting before induction till entry to abdominal cavity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Severe preeclamptic parturients with single fetus pregnancy with contraindication to regional anesthesia
Key exclusion criteria (6 listed)
- Known allergy to study drugs
- Known fetal anomaly and /or gestation week and /or estimated to be nonviable (fetal weight <400 gr, gestational week<24 weeks)
- Known cardiac disease diagnosed prior to pregnancy
- Known drug abuse in the parturient
- Multifetal gestation
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: Ultiva1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion | Drug | R |
| SalineAlso: % 0.9 NaClsame volume iv bolus before induction followed by same volume infusion | Drug | C |
Primary outcome
Blood pressure
Time frame: Induction to post-intubation period
3 secondary outcomes
Heart rate
Time frame: Induction to delivery
Amount of additional drugs and fluids if required
Time frame: Induction to delivery
Evaluation of the newborn
Time frame: Within 10 min following delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2007.
- Background: PubMed 16394684Ngan Kee WD, Khaw KS, Ma KC, Wong AS, Lee BB, Ng FF. Maternal and neonatal effects of remifentanil at induction of general anesthesia for cesarean delivery: a randomized, double-blind, controlled trial. Anesthesiology. 2006 Jan;104(1):14-20. doi: 10.1097/00000542-200601000-00004.
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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.
Tulay Ozkan Seyhan, Associate Prof principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Saline in people with Pre-Eclampsia and Hypertension, Pregnancy-Induced, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 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 5 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Tulay Ozkan Seyhan, Associate Prof. (+90 212 631 87 67, tulay2000@e-kolay.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Induction to post-intubation period). 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 NCT00567957, which also lists 1 linked publication.
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 5 Dec 2007.