Cesarean Section ComplicationsPhase 4NCT03248791
Vasopressor Infusion in Cesarean Delivery
A Phase 4 study testing Phenylephrine, Norepinephrine and Bupivacaine in people with Cesarean Section Complications and Spinal Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications, Spinal Anesthesia
- What is being tested?
- Phenylephrine, Norepinephrine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2017to 10 Mar 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full term
- pregnant women
- scheduled for cesarean section
Who cannot join
- pre-ecpamsia
- eclampsia
- bleeding
- cardiac dysfuction
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
ahmed Shash, Professor, +201001033999
About this study
Official title: Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.
Read the detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.
- Conditions
- Cesarean Section Complications, Spinal Anesthesia
- Being tested
- Phenylephrine, Norepinephrine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
NorepinephrineDrug
Also called noradrenaline
Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.
BupivacaineDrug
Also called Marcaine
Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Active comparator | Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure Receives: Drug: Phenylephrine; Drug: Bupivacaine |
| Norepinephrine | Experimental | Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure Receives: Drug: Norepinephrine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-spinal anesthesia hypotension
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
Measured: 30 minutes after spinal anesthesia
Secondary outcomes (7)
incidence of severe post-spinal anesthesia hypotension
Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading
Measured: 30 minutes after spinal anesthesia
incidence of severe delivery hypotension
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
Measured: 10 minutes after delivery
systolic blood pressure
systolic blood pressure measured in mmHg
Measured: 2 hours after subarachnoid block
diastolic blood pressure
diastolic blood pressure measured in mmHg
Measured: 2 hours after subarachnoid block
heart rate
number of heart beats per minute
Measured: 2 hours after subarachnoid block
APGAR score
APGAR score of the fetus
Measured: 10 minutes after delivery
incidence of reactive hypertension
Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading
Measured: 2 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 posted14 Aug 2017
- Study start20 Aug 2017
- Primary completion1 Mar 2022 (estimated)
- Study completion10 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248791
- Sponsor's protocol ID
- N-86-2017
- Status last verified
- Sep 2021
- First submitted
- 10 Aug 2017
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03248791
- Acronym / sponsor ID
- N-86-2017
- Conditions
- Cesarean Section Complications, Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 10 Mar 2022 (estimated)
- First posted
- 14 Aug 2017 (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.
Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.
Detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Active comparator | Drug: Phenylephrine, Drug: BupivacaineWill receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure |
| Norepinephrine | Experimental | Drug: Norepinephrine, Drug: BupivacaineWill receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full term
- pregnant women
- scheduled for cesarean section
Key exclusion criteria (4 listed)
- pre-ecpamsia
- eclampsia
- bleeding
- cardiac dysfuction
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 |
|---|---|---|
| PhenylephrinePhenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min. | Drug | Phenylephrine |
| NorepinephrineAlso: noradrenalineNorepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min. | Drug | Norepinephrine |
| BupivacaineAlso: MarcaineBupivacaine will be injected in the subarachnoid space with a dose of 10 mg | Drug | Norepinephrine, Phenylephrine |
Primary outcome
incidence of post-spinal anesthesia hypotension
Time frame: 30 minutes after spinal anesthesia
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
7 secondary outcomes
incidence of severe post-spinal anesthesia hypotension
Time frame: 30 minutes after spinal anesthesia
incidence of severe delivery hypotension
Time frame: 10 minutes after delivery
systolic blood pressure
Time frame: 2 hours after subarachnoid block
diastolic blood pressure
Time frame: 2 hours after subarachnoid block
heart rate
Time frame: 2 hours after subarachnoid block
APGAR score
Time frame: 10 minutes after delivery
incidence of reactive hypertension
Time frame: 2 hours after spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Ahmed Mukhtar, Professor study director
Head of research committee section in anesthesia department
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 Phenylephrine, Norepinephrine and Bupivacaine in people with Cesarean Section Complications and Spinal Anesthesia, run by Cairo 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 3 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: status not confirmed, as of the sponsor's last update on 27 Sep 2021. 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. 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 Ahmed Hasanin, Professor (+201095076954, ahmedmohamedhasanin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of post-spinal anesthesia hypotension (time frame: 30 minutes 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 27 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.