Complication of Anaesthesia During Labour and DeliveryNCT04010318
Plethysmographic Variability Index in Post Spinal Anesthesia Hypotension in Cesarean Section
An observational study of Complication of Anaesthesia During Labour and Delivery, run by Tanta University at 2 sites in Egypt.
Trial summary
Full term pregnant female patients presented for elective C.S for single viable fetus will be included in this study. Before anesthesia, the patient will be attached to a monitor of: ECG , heart rate, non invasive blood pressure, pulse taximeter applied on the index finger of the limb not attached to the blood… Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Complication of Anaesthesia During Labour and Delivery
- What is being tested?
- Spinal Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Aug 2019to 11 Feb 2021
- 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 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Full term pregnant female patients presented for elective cesarean section delivery of a single viable fetus under spinal anesthesia/
Who may be able to join
- Pregnant women which are listed to undergo elective caeserian section for single viable baby under spinal anesthesia.
Who cannot join
- Patients with pregnancy less than 36 weeks or more than 40 weeks, Patients with hypertension , pre-eclampsia , eclampsia, Patients with diabetes, Patients with cardiovascular disease and /or arrhythmia, Patients with placenta previa , accreta, percreta, Obese patients with BMI >36, or Polyhydramnious patients.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Tanta University Hospitals
Tanta, Algharbia Governate, 31511
Tanta University hospitals
Tanta, 31511
About this study
Official title: The Sensitivity of Goal Plethysmography Variability Index (PVI) Directed Pre-anesthesia Intravenous Fluid Infusion in the Prevention of Spinal Anesthesia Induced Hypotension in Elective Caesarian Section: Prospective Observational Study
- Full term pregnant female patients presented for elective C.S for single viable fetus will be included in this study.
- Before anesthesia, the patient will be attached to a monitor of: ECG , heart rate, non invasive blood pressure, pulse taximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and plethysmographic variability index (PVI) and perfusion index (PI) will be taken by (Massimo radical 7, Massimo corp. USA). Measures will be recorded every 5 minutes preoperative.
- Patients with PVI <15 will be excluded from the study.
- Patients with PVI > 15 are started on intravenous infusion of warm ringer lactate solution via suitable pore intravenous cannula to reach target of PVI <15 or a total 1 liter of ringer lactate.
- The patients in which the PVI is corrected by fluid to level below 15 will be Group (C) or corrected group. Patients in which intravenous fluid administration did not result any change in PVI or changed but still higher than 15 will be Group (NC) or non corrected group.
After preoperative preparation patient is shifted to operating theater, with all monitors applied. She will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees,
Read the detailed description
- This prospective observational study will be carried out on all pregnant women who will undergo elective cesarean section in obstetric department in Tanta university hospitals under spinal anesthesia over four month duration that starts immediately after obtaining ethical committee approval, an informed written consent will be included with the consent for spinal anesthesia for cesarean section, all patients data will be confidential and will be used for the current study only.
- Inclusion criteria:
Pregnant women which are listed to undergo elective caeserian section for single viable baby under spinal anesthesia.
- Exclusion criteria:
- Patients with pregnancy less than 36 weeks or more than 40 weeks
- Patients with hypertension , pre-eclampsia , eclampsia.
- Patients with diabetes
- Patients with cardiovascular disease and /or arrhythmia.
- Patients with placenta previa, accreta, percreta.
- Obese patients with BMI >36
- Polyhydramnious patients
- On arrival of patients to pre-anaesthesia preparation room, we will allow patients to rest in supine position with 15 degree left tilt by pillow wedge under right hip, after allowing patient to rest for five minutes, measures are recorded: ECG , heart rate, non invasive blood pressure, pulse oximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and Plethysmography variability index (PVI) and perfusion index (PI) will be taken by (Massimo radical 7, Massimo corp. USA). Measures will be recorded every 5 minutes preoperative. Patients with PVI <15 are excluded from the study.
Patients with PVI > 15 are started on intravenous infusion of warm ringer lactate solution via suitable pore intravenous cannula to reach target of PVI <15 or a total 1 liter of ringer lactate.
The patients in which the PVI is corrected by fluid to level below 15 will be Group (C) or corrected group. Patients in which intravenous fluid administration did not result any change in PVI or changed but still higher than 15 will be Group (NC) or non corrected group.
After preoperative preparation patient is shifted to operating theater, with all monitors applied. She will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at rate of 4 liter/minute is applied.
Measurements will be taken every minute till delivery of the baby, and if the blood pressure is decreased below 20% of the baseline level before anesthesia, patients will be given incremental doses of ephedrine sulfate 0.1 mg /kg till blood pressure normalized above 80% of pre-anesthesia level. All measurements will be recorded in tables and subjected to statistical analysis.
- Being tested
- Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
The patients will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at rate of 4 liter/minute is applied.
| Study group | Role | What they receive |
|---|---|---|
| Corrected group | The patients in which the PVI will corrected by fluid to level below 15 Receives: Procedure: Spinal Anesthesia | |
| Uncorrected group | Patients in which intravenous fluid administration didn't result any change in PVI or changed but still higher than 15 Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-spinal anesthesia hypotension
The decrease in the mean arterial pressure below 65 mmHg or below 80% of the baseline value.
Measured: Through out the whole intraoperative period
Secondary outcomes (1)
The consumption of vasopressors
The total dose of ephedrine required to maintain the MAP above 80% of the baseline value
Measured: Through out the whole intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start15 Aug 2019
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Anaesthesia During Labour and DeliveryStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Tamer Mohamed Naguib, Amr Ahmed Magdy
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Ismaiel, M.D, Principal investigator, Lecturer of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010318
- Sponsor's protocol ID
- 33109/05/19
- Status last verified
- Mar 2021
- First submitted
- 3 Jul 2019
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once the study had been successfully completed, the data will be shared for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sensitivity of Goal Plethysmography Variability Index (PVI) Directed Pre-anesthesia Intravenous Fluid Infusion in the Prevention of Spinal Anesthesia Induced Hypotension in Elective Caesarian Section: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04010318
- Acronym / sponsor ID
- 33109/05/19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Tamer Mohamed Naguib, Amr Ahmed Magdy
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 8 Jul 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.
- Full term pregnant female patients presented for elective C.S for single viable fetus will be included in this study.
- Before anesthesia, the patient will be attached to a monitor of: ECG , heart rate, non invasive blood pressure, pulse taximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and plethysmographic variability index (PVI) and perfusion index (PI) will be taken by (Massimo radical 7, Massimo corp. USA). Measures will be recorded every 5 minutes preoperative.
- Patients with PVI <15 will be excluded from the study.
- Patients with PVI > 15 are started on intravenous infusion of warm ringer lactate solution via suitable pore intravenous cannula to reach target of PVI <15 or a total 1 liter of ringer lactate.
- The patients in which the PVI is corrected by fluid to level below 15 will be Group (C) or corrected group. Patients in which intravenous fluid administration did not result any change in PVI or changed but still higher than 15 will be Group (NC) or non corrected group.
After preoperative preparation patient is shifted to operating theater, with all monitors applied. She will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees,
Detailed description
- This prospective observational study will be carried out on all pregnant women who will undergo elective cesarean section in obstetric department in Tanta university hospitals under spinal anesthesia over four month duration that starts immediately after obtaining ethical committee approval, an informed written consent will be included with the consent for spinal anesthesia for cesarean section, all patients data will be confidential and will be used for the current study only.
- Inclusion criteria:
Pregnant women which are listed to undergo elective caeserian section for single viable baby under spinal anesthesia.
- Exclusion criteria:
- Patients with pregnancy less than 36 weeks or more than 40 weeks
- Patients with hypertension , pre-eclampsia , eclampsia.
- Patients with diabetes
- Patients with cardiovascular disease and /or arrhythmia.
- Patients with placenta previa, accreta, percreta.
- Obese patients with BMI >36
- Polyhydramnious patients
- On arrival of patients to pre-anaesthesia preparation room, we will allow patients to rest in supine position with 15 degree left tilt by pillow wedge under right hip, after allowing patient to rest for five minutes, measures are recorded: ECG , heart rate, non invasive blood pressure, pulse oximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and Plethysmography variability index (PVI) and perfusion index (PI) will be taken by (Massimo radical 7, Massimo corp. USA). Measures will be recorded every 5 minutes preoperative. Patients with PVI <15 are excluded from the study.
Patients with PVI > 15 are started on intravenous infusion of warm ringer lactate solution via suitable pore intravenous cannula to reach target of PVI <15 or a total 1 liter of ringer lactate.
The patients in which the PVI is corrected by fluid to level below 15 will be Group (C) or corrected group. Patients in which intravenous fluid administration did not result any change in PVI or changed but still higher than 15 will be Group (NC) or non corrected group.
After preoperative preparation patient is shifted to operating theater, with all monitors applied. She will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at rate of 4 liter/minute is applied.
Measurements will be taken every minute till delivery of the baby, and if the blood pressure is decreased below 20% of the baseline level before anesthesia, patients will be given incremental doses of ephedrine sulfate 0.1 mg /kg till blood pressure normalized above 80% of pre-anesthesia level. All measurements will be recorded in tables and subjected to statistical analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corrected group | – | Procedure: Spinal AnesthesiaThe patients in which the PVI will corrected by fluid to level below 15 |
| Uncorrected group | – | Procedure: Spinal AnesthesiaPatients in which intravenous fluid administration didn't result any change in PVI or changed but still higher than 15 |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Full term pregnant female patients presented for elective cesarean section delivery of a single viable fetus under spinal anesthesia/
Key inclusion criteria (1 listed)
- Pregnant women which are listed to undergo elective caeserian section for single viable baby under spinal anesthesia.
Key exclusion criteria (1 listed)
- Patients with pregnancy less than 36 weeks or more than 40 weeks, Patients with hypertension , pre-eclampsia , eclampsia, Patients with diabetes, Patients with cardiovascular disease and /or arrhythmia, Patients with placenta previa , accreta, percreta, Obese patients with BMI >36, or Polyhydramnious patients.
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 |
|---|---|---|
| Spinal AnesthesiaThe patients will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at rate of 4 liter/minute is applied. | Procedure or surgery | Corrected group, Uncorrected group |
Primary outcome
The incidence of post-spinal anesthesia hypotension
Time frame: Through out the whole intraoperative period
The decrease in the mean arterial pressure below 65 mmHg or below 80% of the baseline value.
1 secondary outcome
The consumption of vasopressors
Time frame: Through out the whole intraoperative period
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 26 Mar 2021.
- Individual participant dataSharing planned: Undecided. Once the study had been successfully completed, the data will be shared for other researchers.
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.
Sameh Ismaiel, M.D principal investigator
Lecturer of Anesthesia and Intensive Care, Tanta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Anaesthesia During Labour and Delivery, run by Tanta University at 2 sites 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: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The incidence of post-spinal anesthesia hypotension (time frame: Through out the whole intraoperative period). 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 26 Mar 2021.