Cesarean Section ComplicationsPhase 4NCT03328533
Norepinephrine Versus Phenylephrine Continuous Variable 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 Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) 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
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2017to 5 May 2018
- 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-eclampsia
- Eclampsia
- Bleeding
- Cardiac dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial
Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) 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, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.
- 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 Levophed
Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 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. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred. Receives: Drug: Phenylephrine; Drug: Bupivacaine |
| Norepinephrine | Experimental | Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred. 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 (13)
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
Heart rate
number of heart beats per minute
Measured: 2 hours after subarachnoid block
APGAR score for assessment of the general state of the fetus
APGAR score of the fetus ranging from 0 to 10. the higher the value, the better he score
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
Umbilical arterial potential hydrogen (PH)
PH in the blood sample obtained from umbilical artery scaled from 1 to 14
Measured: 10 minutes after delivery
Umbilical arterial Partial pressure of Carbon dioxide
in the blood sample obtained from umbilical artery measured in mmHg
Measured: 10 minutes after delivery
incidence of nausea
The percentage of patients with nausea
Measured: 2 hours
Incidence of vomiting
The percentage of patients with nausea
Measured: 2 hours
Total phenylephrine consumption
the total dose of phenylephrine consumed during the operation
Measured: 2 hours
Total norepinephrine consumption
the total dose of norepinephrine consumed during the operation
Measured: 2 hours
Total ephedrine consumption
the total dose of ephedrine consumed during the operation
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 posted1 Nov 2017
- Study start10 Nov 2017
- Primary completion1 May 2018
- Study completion5 May 2018
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, Care provider, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed M Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328533
- Sponsor's protocol ID
- N-82-2017
- Status last verified
- Jul 2018
- First submitted
- 30 Oct 2017
- Last updated
- 17 Jul 2018
- 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 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT03328533
- Acronym / sponsor ID
- N-82-2017
- Conditions
- Cesarean Section Complications, Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 1 Nov 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 Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) 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, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.
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 |
|---|---|---|
| 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. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred. |
| Norepinephrine | Experimental | Drug: Norepinephrine, Drug: BupivacaineWill receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred. |
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-eclampsia
- Eclampsia
- Bleeding
- Cardiac dysfunction
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: LevophedNorepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 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
13 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
Heart rate
Time frame: 2 hours after subarachnoid block
APGAR score for assessment of the general state of the fetus
Time frame: 10 minutes after delivery
Incidence of reactive hypertension
Time frame: 2 hours after spinal anesthesia
Umbilical arterial potential hydrogen (PH)
Time frame: 10 minutes after delivery
Umbilical arterial Partial pressure of Carbon dioxide
Time frame: 10 minutes after delivery
incidence of nausea
Time frame: 2 hours
Incidence of vomiting
Time frame: 2 hours
Total phenylephrine consumption
Time frame: 2 hours
Total norepinephrine consumption
Time frame: 2 hours
Total ephedrine consumption
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 17 Jul 2018.
- Individual participant dataSharing planned: No
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LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
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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 M 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: finished, as of the sponsor's last update on 17 Jul 2018. 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?
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 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 17 Jul 2018.