Cesarean Section ComplicationsPhase 4NCT03302039
Three Protocols for Phenylephrine Administration in Cesarean Delivery
A Phase 4 study testing Single shot phenylephrine, Fixed infusion phenylephrine. and Variable infusion phenylephrine. in people with Cesarean Section Complications and Spinal Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine. 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?
- Single shot phenylephrine, Fixed infusion phenylephrine. and Variable infusion phenylephrine.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2017to 15 Oct 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 delivery
Who cannot join
- Pre-eclampsia
- Eclampsia
- Hemorrhage
- Cardiac dysfunction
- Baseline low heart rate (below 60 bpm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Protocols for Phenylephrine Administration for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery
The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.
Read the detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).
- Conditions
- Cesarean Section Complications, Spinal Anesthesia
- Being tested
- Single shot phenylephrine, Fixed infusion phenylephrine., Variable infusion phenylephrine., Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single shot phenylephrineDrug
Also called Phenylephrine
A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.
Fixed infusion phenylephrine.Drug
Also called Phenylephrine
Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min
Variable infusion phenylephrine.Drug
Also called Phenylephrine
Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
BupivacaineDrug
Also called Marcaine
Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Single shot | Experimental | Spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered. Receives: Drug: Single shot phenylephrine; Drug: Bupivacaine |
| Fixed infusion | Active comparator | Spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred. Receives: Drug: Fixed infusion phenylephrine.; Drug: Bupivacaine |
| Variable infusion | Active comparator | Spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure. Receives: Drug: Variable infusion phenylephrine.; 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 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: 30 minutes after spinal anesthesia
Secondary outcomes (8)
Incidence of severe Post-spinal anesthesia hypotension
Defined as percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery of the fetus.
Measured: 30 minutes after spinal anesthesia
Incidence of reactive hypertension
Defined as percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.
Measured: 2 hours after spinal anesthesia
Systolic blood pressure
Systolic blood pressure measured in mmHg
Measured: 2 hours after spinal anesthesia
Diastolic blood pressure
Diastolic blood pressure measured in mmHg
Measured: 2 hours after spinal anesthesia
Heart rate
number of heart beats per minute
Measured: 2 hours after spinal anesthesia
APGAR score
APGAR score of the fetus
Measured: 10 minutes after delivery
umbilical arterial PH
the PH in umbilical arterial blood
Measured: 10 minutes after delivery
umbilical arterial Pco2
umbilical arterial Pco2 measured in mmHg
Measured: 10 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start6 Oct 2017
- Primary completion1 Oct 2018
- Study completion15 Oct 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, Investigator, Outcomes assessor
- Enrolment
- 217 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 Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302039
- Sponsor's protocol ID
- N-71-2017
- Status last verified
- Dec 2018
- First submitted
- 1 Oct 2017
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Protocols for Phenylephrine Administration for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03302039
- Acronym / sponsor ID
- N-71-2017
- Conditions
- Cesarean Section Complications, Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 4 Oct 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.
The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.
Detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single shot | Experimental | Drug: Single shot phenylephrine, Drug: BupivacaineSpinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered. |
| Fixed infusion | Active comparator | Drug: Fixed infusion phenylephrine., Drug: BupivacaineSpinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred. |
| Variable infusion | Active comparator | Drug: Variable infusion phenylephrine., Drug: BupivacaineSpinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to 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 delivery
Key exclusion criteria (5 listed)
- Pre-eclampsia
- Eclampsia
- Hemorrhage
- Cardiac dysfunction
- Baseline low heart rate (below 60 bpm)
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 |
|---|---|---|
| Single shot phenylephrineAlso: PhenylephrineA single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously. | Drug | Single shot |
| Fixed infusion phenylephrine.Also: PhenylephrineFixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min | Drug | Fixed infusion |
| Variable infusion phenylephrine.Also: PhenylephrineVariable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min. | Drug | Variable infusion |
| BupivacaineAlso: MarcaineBupivacaine will be administrated in the subarachnoid space for spinal anesthesia. | Drug | Fixed infusion, Single shot, Variable infusion |
Primary outcome
Incidence of Post-spinal anesthesia hypotension
Time frame: 30 minutes after spinal anesthesia
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
8 secondary outcomes
Incidence of severe Post-spinal anesthesia hypotension
Time frame: 30 minutes after spinal anesthesia
Incidence of reactive hypertension
Time frame: 2 hours after spinal anesthesia
Systolic blood pressure
Time frame: 2 hours after spinal anesthesia
Diastolic blood pressure
Time frame: 2 hours after spinal anesthesia
Heart rate
Time frame: 2 hours after spinal anesthesia
APGAR score
Time frame: 10 minutes after delivery
umbilical arterial PH
Time frame: 10 minutes after delivery
umbilical arterial Pco2
Time frame: 10 minutes after delivery
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 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
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Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
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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 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 Single shot phenylephrine, Fixed infusion phenylephrine. and Variable infusion phenylephrine. 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 5 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 Dec 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 Dec 2018.