Anesthetic Complication SpinalPhase 4NCT01378325
Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery
A Phase 4 study testing Phenylephrine and saline in people with Anesthetic Complication Spinal, run by American University of Beirut Medical Center.
Trial summary
Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload) to be more effective in terms of managing hypotension as compared to administering crystalloid before spinal anesthesia (preload). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthetic Complication Spinal
- What is being tested?
- Phenylephrine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parturients beyond 37 weeks gestation
- ASA І or ІІ
Who cannot join
- pregnancy-induced hypertension
- chronic hypertension
- multiple pregnancy
- fetal compromise
- diabetes mellitus
- polyhydramnios
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- body weight >100 kg
- major systemic disease
- anemia (hemoglobin concentration<10 g/dl)
- clotting diathesis
About this study
Official title: Crystalloid Coload Combined With Variable Rate Phenylephrine Infusion for Prevention of Hypotension During Spinal Anesthesia for Elective Cesarean Delivery vs Crystalloid Coload Alone
Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload) to be more effective in terms of managing hypotension as compared to administering crystalloid before spinal anesthesia (preload).
Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid coload up to two liters (administration at the time of SA). However, incidence of reactive hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise concern in patients in whom increase of blood pressure may be detrimental, like chronic hypertension and in the presence of a compromised uteroplacental blood flow. A recent study found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min respectively. However, there was no reduction in the number of physician interventions (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have limited application in clinical practice, and a variable rate (i.e. modifying the rate according to hemodynamics) has been advocated. The bolus administration of phenylephrine to treat hypotension is still commonly used, but requests multiple interventions from the anesthesiologists and is time consuming.
Read more
Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will receive infusion of normal saline (placebo) and patients in group II variable infusion rate of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed infusion rate). The number of interventions needed to maintain maternal systolic blood pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting, and umbilical cord blood gases will be compared between the two groups.
We will define a reliable and safe method to ensure maternal hemodynamic stability during spinal anesthesia for cesarean delivery with the least physician interference.
- Conditions
- Anesthetic Complication Spinal
- Being tested
- Phenylephrine, saline
- Keywords
- spinal, cesarean delivery, phenylephrine, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Neosynephrine
Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline
salineDrug
Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery Receives: Drug: Phenylephrine |
| Saline | Placebo comparator | Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:
- stopping the phenylephrine infusion
- changing the rate of phenylephrine infusion
- rescue intravenous bolus of phenylephrine (100 µg) for hypotension
- rescue intravenous bolus of atropine (0.4 mg) for bradycardia
Measured: Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthetic Complication SpinalStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Sayyid, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378325
- Sponsor's protocol ID
- ANES.SS.10
- Status last verified
- Aug 2014
- First submitted
- 10 Jun 2011
- Last updated
- 26 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crystalloid Coload Combined With Variable Rate Phenylephrine Infusion for Prevention of Hypotension During Spinal Anesthesia for Elective Cesarean Delivery vs Crystalloid Coload Alone
- ClinicalTrials.gov ID
- NCT01378325
- Acronym / sponsor ID
- ANES.SS.10
- Conditions
- Anesthetic Complication Spinal
- Keywords
- spinal, cesarean delivery, phenylephrine, hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Posted 26 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload) to be more effective in terms of managing hypotension as compared to administering crystalloid before spinal anesthesia (preload).
Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid coload up to two liters (administration at the time of SA). However, incidence of reactive hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise concern in patients in whom increase of blood pressure may be detrimental, like chronic hypertension and in the presence of a compromised uteroplacental blood flow. A recent study found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min respectively. However, there was no reduction in the number of physician interventions (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have limited application in clinical practice, and a variable rate (i.e. modifying the rate according to hemodynamics) has been advocated. The bolus administration of phenylephrine to treat hypotension is still commonly used, but requests multiple interventions from the anesthesiologists and is time consuming.
Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will receive infusion of normal saline (placebo) and patients in group II variable infusion rate of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed infusion rate). The number of interventions needed to maintain maternal systolic blood pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting, and umbilical cord blood gases will be compared between the two groups.
We will define a reliable and safe method to ensure maternal hemodynamic stability during spinal anesthesia for cesarean delivery with the least physician interference.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: PhenylephrinePHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery |
| Saline | Placebo comparator | Drug: salineProphylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Parturients beyond 37 weeks gestation
- ASA І or ІІ
Key exclusion criteria (10 listed)
- pregnancy-induced hypertension
- chronic hypertension
- multiple pregnancy
- fetal compromise
- diabetes mellitus
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 |
|---|---|---|
| PhenylephrineAlso: NeosynephrineProphylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline | Drug | Phenylephrine |
| salineProphylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline | Drug | Saline |
Primary outcome
Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
Time frame: Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).
Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following: * stopping the phenylephrine infusion * changing the rate of phenylephrine infusion * rescue intravenous bolus of phenylephrine (100 µg) for hypotension * rescue intravenous bolus of atropine (0.4 mg) for bradycardia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Phase 4 study testing Phenylephrine and saline in people with Anesthetic Complication Spinal, run by American University of Beirut Medical Center.
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 2 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: finished, as of the sponsor's last update on 26 Aug 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. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery. (time frame: Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).). 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 26 Aug 2014.