Perfusion Index Predicts Post-spinal HypotensionNCT04186091
Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section
An observational study of Perfusion Index Predicts Post-spinal Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients. The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perfusion Index Predicts Post-spinal Hypotension
- What is being tested?
- correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 30 Jul 2018
- How long will I take part?
- 1 Day
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 \&40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.
Who may be able to join
- Fifty parturient
- Aged between 18- 40,
- ASA I and II
- With term singleton pregnancies
- With 25 ≥ BMI≤ 40
- Conducted for cesarean section under spinal anesthesia
Who cannot join
- Emergency cases,
- Placenta previa,
- Preeclampsia,
- Cardiovascular and cerebrovascular diseases,
- Patient with contraindication for regional anesthesia
- Patient with peripheral vascular diseases as DVT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section-A Prospective Observational Study
Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.
The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.
Read the detailed description
Abstract Background Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.
The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.
Methods After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 \&40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.
- Being tested
- correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correlation between baseline perfusion index and decrease in systolic blood pressure post spinal inductionProcedure or surgery
correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between baseline perfusion index and post spinal decrease in systolic blood pressure
correlation between baseline perfusion index and post spinal decrease in systolic blood pressure
Measured: 24 hours Postoperative
Secondary outcomes (1)
correlation between BMI and the incidence of post-spinal hypotension
correlation between BMI and the incidence of post-spinal hypotension
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Apr 2017
- Primary completion9 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion Index Predicts Post-spinal HypotensionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ahmed Abdalla Mohamed, M.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186091
- Sponsor's protocol ID
- N-5- 2017
- Status last verified
- Dec 2019
- First submitted
- 1 Dec 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till submission
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section-A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04186091
- Acronym / sponsor ID
- N-5- 2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 4 Dec 2019 (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.
Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.
The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.
Detailed description
Abstract Background Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.
The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.
Methods After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 \&40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 \&40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.
Key inclusion criteria (6 listed)
- Fifty parturient
- Aged between 18- 40,
- ASA I and II
- With term singleton pregnancies
- With 25 ≥ BMI≤ 40
Key exclusion criteria (6 listed)
- Emergency cases,
- Placenta previa,
- Preeclampsia,
- Cardiovascular and cerebrovascular diseases,
- Patient with contraindication for regional anesthesia
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 |
|---|---|---|
| correlation between baseline perfusion index and decrease in systolic blood pressure post spinal inductioncorrelation between baseline perfusion index and decrease in systolic blood pressure post spinal induction | Procedure or surgery | – |
Primary outcome
correlation between baseline perfusion index and post spinal decrease in systolic blood pressure
Time frame: 24 hours Postoperative
correlation between baseline perfusion index and post spinal decrease in systolic blood pressure
1 secondary outcome
correlation between BMI and the incidence of post-spinal hypotension
Time frame: 24 hours Postoperative
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 4 Dec 2019.
- Individual participant dataSharing planned: Undecided. Till submission
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 Abdalla Mohamed, M.D study director
Cairo University
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 Perfusion Index Predicts Post-spinal Hypotension, 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 6 inclusion and 6 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 4 Dec 2019. 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?
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?
correlation between baseline perfusion index and post spinal decrease in systolic blood pressure (time frame: 24 hours Postoperative). 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 4 Dec 2019.