Anesthesia, ObstetricalPhase 2NCT02958215
Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section
A Phase 2 study testing Phenylephrine in people with Anesthesia, Obstetrical and Anesthesia, Spinal, run by Assiut University at 1 site in Egypt.
Trial summary
Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Anesthesia, Obstetrical, Anesthesia, Spinal
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 980 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to May 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.
Who cannot join
- Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine
Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia
Read the detailed description
Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.
- Conditions
- Anesthesia, Obstetrical, Anesthesia, Spinal
- Being tested
- Phenylephrine, Placebo
- Keywords
- Orthostatic, Cesarean section, Pregnant, Phenyephrine, 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
it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section
PlaceboOther
5 ml normal saline will be given before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension Receives: Other: Placebo |
| Group B | Active comparator | This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block
Measured: within first 24 hours after spinal anesthesia
Secondary outcomes (4)
Frequency of bradycardia
heart rate will be measured every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block
Measured: within first 24 hours after spinal anesthesia
Ephedrine usage
Total amount of ephedrine given
Measured: within first 24 hours after spinal anesthesia
intraoperative fluid management
Total amount of fluid given
Measured: within first 24 hours after spinal anesthesia
Apgar scores
Apgar scores in the first and fifth minutes of the newborns
Measured: within first 24 hours after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ObstetricalStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- Sayed K Abd-Elshafy, MD, Principal investigator, Associate professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958215
- Sponsor's protocol ID
- IRB0000871230
- Status last verified
- May 2017
- First submitted
- 4 Nov 2016
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine
- ClinicalTrials.gov ID
- NCT02958215
- Acronym / sponsor ID
- IRB0000871230
- Conditions
- Anesthesia, Obstetrical, Anesthesia, Spinal
- Keywords
- Orthostatic, Cesarean section, Pregnant, Phenyephrine, Hypotension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Nov 2016 (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.
Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia
Detailed description
Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: PlaceboThis group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension |
| Group B | Active comparator | Drug: PhenylephrineThis group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.
Key exclusion criteria (1 listed)
- Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.
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 |
|---|---|---|
| Phenylephrineit will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section | Drug | Group B |
| Placebo5 ml normal saline will be given before spinal anesthesia | Other | Group A |
Primary outcome
Incidence of hypotension
Time frame: within first 24 hours after spinal anesthesia
blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block
4 secondary outcomes
Frequency of bradycardia
Time frame: within first 24 hours after spinal anesthesia
Ephedrine usage
Time frame: within first 24 hours after spinal anesthesia
intraoperative fluid management
Time frame: within first 24 hours after spinal anesthesia
Apgar scores
Time frame: within first 24 hours after spinal anesthesia
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 18 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Sayed K Abd-Elshafy, MD principal investigator
Associate professor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenylephrine in people with Anesthesia, Obstetrical and Anesthesia, Spinal, run by Assiut University at 1 site in Egypt.
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 18 May 2017. 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 Egypt. 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 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 hypotension (time frame: within first 24 hours after spinal anesthesia). 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 May 2017.