AnesthesiaNCT06220942
Tachycardia as an Indication for Prophylactic Phenylephrine Injection in Caesarean Section Under Spinal Anesthesia; an Observational Study
An observational study of Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The value of phenylephrine administration in response to tachycardia in preventing hypotension after spinal anesthesia in elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2023to May 2024
- Phase
- Observational
- 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
Study population: Pregnant female at childbearing period
Who may be able to join
- ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.
Who cannot join
- Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI patients with cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
maha sadek El Derh
Cairo, Heliopolis, 11721
maha S El Derh, MD, 01144866675, mahasadek81@yahoo.com
samar M Abd el tawab, MD, 01006236494, dr_sm.md@hotmail.com
About this study
The value of phenylephrine administration in response to tachycardia in preventing hypotension after spinal anesthesia in elective cesarean section.
Read the detailed description
This observational study will take place at Ain Shams University Maternity hospitals, Cairo, Egypt. All patients will sign written informed consent before inclusion.
Sample size:
Using PASS 15 program for sample size calculation, setting confidence level at 95% and margin of error at 0.05, it is estimated that sample size of 80 women will be needed to detect an expected incidence rate of hypotension after phenylephrine administration of 30% "Hasanin et al., 2019"
Inclusion criteria:
ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.
Exclusion criteria:
Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI \& patients with cardiovascular diseases For all pregnant females including whose in the study group, preoperative labs will be done including ( CBC, INR, Liver function \& Kidney function) , oral and written informed consents will be taken from the patients with explanation of the spinal anesthesia and expected complications.
In OR wide pore IV access and preload started with crystalloids, full standard monitoring, spinal anesthesia will be performed by the expert anesthetist. The pregnant female will be in the sitting position and complete sterilization of her back, local anesthesia by 5 ml lidocaine 1% then the spinal needle (Pencil point 27 G) introduced between L4-5 and injection of (50 µg fentanyl + bupivacaine 0.5%) in total volume between 1.8 - 2.3 according to patient's height.
Then patient will lie supine with head elevated 30 degrees by a bellow and start recording the data just after spinal anesthesia.
Phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline.
Then blood pressure \& HR will be recorded after the administration of phenylephrine and every 5 minutes.
Any further doses given will be recorded.
- Conditions
- Anesthesia
- Being tested
- Phenylephrine
- Keywords
- Caesarean section , hypotension, spinal anesthesia, phenylephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Pregnant female presented for C.S. after receiving spinal anesthesia, recording the vital data, phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Hypotension Avoidance of Hypotension Avoidance of Hypotension
Measure number of hypotensive episodes that would occur after injection of prophylactic phenylephrine for caesarean section ,by spinal anesthesia
Measured: all through the procedure (cesarean section)
Secondary outcomes (1)
Apgar score in neonates. Number of phenylephrine doses. Nausea & vomiting after spinal anesthesia.
Measure Apgar score of neonate after delivery and compare the results with other neonate whose parturients that did not receive prophylactic phenylephrine
Measured: all through the procedure (cesarean section)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start5 Oct 2023
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha sadek El Derh, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220942
- Sponsor's protocol ID
- FMASUR338/2023
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tachycardia as an Indication for Prophylactic Phenylephrine Injection in Caesarean Section Under Spinal Anesthesia; an Observational Study
- ClinicalTrials.gov ID
- NCT06220942
- Acronym / sponsor ID
- FMASUR338/2023
- Conditions
- Anesthesia
- Keywords
- Caesarean section , hypotension, spinal anesthesia, phenylephrine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 24 Jan 2024 (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 value of phenylephrine administration in response to tachycardia in preventing hypotension after spinal anesthesia in elective cesarean section.
Detailed description
This observational study will take place at Ain Shams University Maternity hospitals, Cairo, Egypt. All patients will sign written informed consent before inclusion.
Sample size:
Using PASS 15 program for sample size calculation, setting confidence level at 95% and margin of error at 0.05, it is estimated that sample size of 80 women will be needed to detect an expected incidence rate of hypotension after phenylephrine administration of 30% "Hasanin et al., 2019"
Inclusion criteria:
ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.
Exclusion criteria:
Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI \& patients with cardiovascular diseases For all pregnant females including whose in the study group, preoperative labs will be done including ( CBC, INR, Liver function \& Kidney function) , oral and written informed consents will be taken from the patients with explanation of the spinal anesthesia and expected complications.
In OR wide pore IV access and preload started with crystalloids, full standard monitoring, spinal anesthesia will be performed by the expert anesthetist. The pregnant female will be in the sitting position and complete sterilization of her back, local anesthesia by 5 ml lidocaine 1% then the spinal needle (Pencil point 27 G) introduced between L4-5 and injection of (50 µg fentanyl + bupivacaine 0.5%) in total volume between 1.8 - 2.3 according to patient's height.
Then patient will lie supine with head elevated 30 degrees by a bellow and start recording the data just after spinal anesthesia.
Phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline.
Then blood pressure \& HR will be recorded after the administration of phenylephrine and every 5 minutes.
Any further doses given will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant female at childbearing period
Key inclusion criteria (1 listed)
- ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.
Key exclusion criteria (1 listed)
- Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI patients with cardiovascular diseases
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 |
|---|---|---|
| PhenylephrinePregnant female presented for C.S. after receiving spinal anesthesia, recording the vital data, phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline | Drug | – |
Primary outcome
Occurrence of Hypotension Avoidance of Hypotension Avoidance of Hypotension
Time frame: all through the procedure (cesarean section)
Measure number of hypotensive episodes that would occur after injection of prophylactic phenylephrine for caesarean section ,by spinal anesthesia
1 secondary outcome
Apgar score in neonates. Number of phenylephrine doses. Nausea & vomiting after spinal anesthesia.
Time frame: all through the procedure (cesarean section)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Ain Shams 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Hypotension Avoidance of Hypotension Avoidance of Hypotension (time frame: all through the procedure (cesarean section)). 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 24 Jan 2024.