Adverse Anesthesia OutcomePhase 2NCT03015857
Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
A Phase 2 study testing phenylephrine, Norepinephrine and Bupivacaine in people with Adverse Anesthesia Outcome, run by Kasr El Aini Hospital.
Trial summary
Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- phenylephrine, Norepinephrine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Apr 2017
- Phase
- Phase 2
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full term singleton parturients
- elective cesarean sections
Who cannot join
- cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- body mass index > 35 will be excluded from the study
About this study
Official title: A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery
Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.
Read the detailed description
On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position.
After spinal block, patients will be randomly allocated into one of two groups:
- Phenylephrine group (n=100)
- Norepinephrine group (n=100)
Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- phenylephrine, Norepinephrine, Bupivacaine, Fentanyl, Placebo (normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenylephrineDrug
- phenylephrine; a vasopressor drug given to prevent post spinal hypotension
NorepinephrineDrug
- norepinephrine; a vasopressor drug given to prevent post spinal hypotension
BupivacaineDrug
intrathecal bupivacaine 10 mg will be given in both groups
FentanylDrug
intrathecal fentanyl 20 mcg will be given in both groups
Placebo (normal saline)Drug
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine, | Active comparator | - Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus. Receives: Drug: phenylephrine; Drug: Bupivacaine; Drug: Fentanyl; Drug: Placebo (normal saline) |
| norepinephrine | Active comparator | - Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus. Receives: Drug: Norepinephrine; Drug: Bupivacaine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
Measured: 2 hours
Secondary outcomes (3)
systolic and diastolic blood pressures measured in mm Hg
Measured: 2 hours
heart rate measured in beats per minute
Measured: 2 hours
nausea and vomiting measured in number of attacks
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Anesthesia OutcomeStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed elsakka, Kasr El Aini Hospital
- Investigators
- Shereen Refaat, M.D., Study chair, Lecturer of anesthesia Faculty of medicine Cairo universityTamer M Rook, M.D., Study chair, Lecturer of anesthesia Faculty of medicine Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015857
- Sponsor's protocol ID
- cesarean sections
- Status last verified
- May 2017
- First submitted
- 5 Dec 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03015857
- Acronym / sponsor ID
- cesarean sections
- Conditions
- Adverse Anesthesia Outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Jan 2017 (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.
Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.
Detailed description
On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position.
After spinal block, patients will be randomly allocated into one of two groups:
- Phenylephrine group (n=100)
- Norepinephrine group (n=100)
Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phenylephrine, | Active comparator | Drug: phenylephrine, Drug: Bupivacaine, Drug: Fentanyl, Drug: Placebo (normal saline)- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus. |
| norepinephrine | Active comparator | Drug: Norepinephrine, Drug: Bupivacaine, Drug: Fentanyl- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- full term singleton parturients
- elective cesarean sections
Key exclusion criteria (4 listed)
- cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- body mass index > 35 will be excluded from the study
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 |
|---|---|---|
| phenylephrine- phenylephrine; a vasopressor drug given to prevent post spinal hypotension | Drug | phenylephrine, |
| Norepinephrine- norepinephrine; a vasopressor drug given to prevent post spinal hypotension | Drug | norepinephrine |
| Bupivacaineintrathecal bupivacaine 10 mg will be given in both groups | Drug | norepinephrine, phenylephrine, |
| Fentanylintrathecal fentanyl 20 mcg will be given in both groups | Drug | norepinephrine, phenylephrine, |
| Placebo (normal saline) | Drug | phenylephrine, |
Primary outcome
Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
Time frame: 2 hours
3 secondary outcomes
systolic and diastolic blood pressures measured in mm Hg
Time frame: 2 hours
heart rate measured in beats per minute
Time frame: 2 hours
nausea and vomiting measured in number of attacks
Time frame: 2 hours
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 3 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Adverse Anesthesia Outcome
RecruitingPhase 4
Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
Analgesics, Opioid, Anesthesia, Spinal
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.
Shereen Refaat, M.D. study chair
Lecturer of anesthesia Faculty of medicine Cairo university
Tamer M Rook, M.D. study chair
Lecturer of anesthesia Faculty of medicine Cairo university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing phenylephrine, Norepinephrine and Bupivacaine in people with Adverse Anesthesia Outcome, run by Kasr El Aini 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 2 inclusion and 4 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 3 May 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) (time frame: 2 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 3 May 2017.