Cesarean SectionNCT04777123
Prevention of Post-spinal Anesthesia Hypotension in Caesarean Delivery Using Delayed Supine Positioning
A study testing sitting position in people with Cesarean Section and Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
Maternal hypotension is a common complication after spinal anaesthesia for caesarean delivery. Prophylaxis against post-spinal hypotension (PSH) during caesarean delivery would prevent serious maternal and fetal complications. Various methods had been investigated for prophylaxis against maternal hypotension. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Hypotension, Spinal Anaesthesia
- What is being tested?
- sitting position
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2021to Jun 2021
- Phase
- Interventional
- 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 (above 37 weeks gestation).
- Singleton.
- Pregnant woman ASA II scheduled for elective caesarean section aged between 18 and 35 years.
Who cannot join
- Contraindications to spinal anaesthesia.
- Obese patients (body mass index >35).
- Peripartum bleeding.
- Impaired cardiac contractility (Ejection fraction<45%).
- Cardiac arrhythmias (I.e. any rhythm other than normal sinus rhythm and sinus tachycardia).
- Valvular heart lesions (I.e. moderate to severe valve lesions).
Show all 9Show fewer
- Pre-existing hypertension, pregnancy induced hypertensive disorders.
- Fetal abnormalities.
- Intraoperative blood loss over 1000 ml and failed/ high subarachnoid block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Post-spinal Anesthesia Hypotension in Caesarean Delivery Using Delayed Supine Positioning: a Randomized Controlled Trial
Maternal hypotension is a common complication after spinal anaesthesia for caesarean delivery. Prophylaxis against post-spinal hypotension (PSH) during caesarean delivery would prevent serious maternal and fetal complications. Various methods had been investigated for prophylaxis against maternal hypotension. The basic components of management of PSH are: 1. Fluid loading. 2. Pharmacological agents. 3. Positioning protocols. Although Fluid loading is superior to non-loading protocols during caesarean delivery, the incidence of Post-spinal hypotension is high with all fluid loading protocols. Thus; the value of fluid loading in caesarean delivery could not be used solely for prevention of PSH. Using vasopressors for prophylaxis against PSH is nearly fundamental during caesarean delivery. However, vasopressors are not devoid of side effects such as reflex bradycardia after phenylephrine and fetal acidosis after ephedrine. Thus, combining vasopressor prophylaxis and non-pharmacological protocols would help to decrease the dose of vasopressors, and consequently decreasing their side effects. Ondansetron had been also reported as a useful prophylactic drug from PSH with minimal side effects. Positioning protocols, such as operating table tilting or flexing, the use of wedges or mechanical displacers, leg wrapping or sequential compression devices, head down and head up positioning aim to reversing aortocaval compression and/or increasing venous return. The sitting position for a short period after spinal block in order to slow the onset of the spinal block. Keeping the patient in the sitting position after spinal block would also prevent extension of local anaesthetic solution to upper thoracic dermatomes which is an important factor in preventing maternal hypotension.
no previous reports had evaluated the impact of sitting position within the context of a multimodal protocol for prophylaxis against maternal hypotension. In this study, we aim to evaluate the impact of 2-minute sitting position after spinal anesthesia on maternal hemodynamics when combined with prophylactic norepinephrine infusion plus preoperative bolus of ondansetron. We aim to reach the best possible maternal hemodynamic profile in addition to maintenance of adequate block level.
Read the detailed description
Upon arrival to operating room, Monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). All measurements will be taken before IV line insertion and premedications. Baseline systolic blood pressure will be obtained in the supine position as the mean of three consecutive readings at 2-minute intervals with a difference of less than 10%.
After insertion of a peripheral 18-gauge line with a three way valve for fluids and vasopressor infusion; Premedication's with ranitidine (50mg) and ondansetron (4 mg) will be administered. Subarachnoid block (SAB) will be done in sitting position under complete asepsis in L3-L4 or L4-L5 interspace using 25 g spinal needle. 11 mg of 0.5% intrathecal hyperbaric Bupivacaine and 25um fentanyl will be administered.
Block success will be assessed using pinprick or sensation to cold besides adequate motor block. Patients with failed SAB (Defined as sensory level below T4) will be excluded as well as patients with high spinal block (defined as spinal anaesthesia in which spinal denervation extends to second or third thoracic dermatome or sometimes up to cervical dermatomes).
Co-hydration will be continued up to a maximum of 1.5 litres (patients with intraoperative blood loss over 1000 ml will be excluded from the study). After delivery of the foetus, oxytocin will be given as an initial bolus of 0.5 IU over five seconds followed by 40 mIU/minute infusion. Inspired air will be supplemented with oxygen 3 l/min via a nasal catheter until delivery.
Continuous norepinephrine fixed rate infusion will be given to both groups as 5 mcg norepinephrine bolus at the same time cerebrospinal fluid obtained followed by norepinephrine infusion in a starting dose of 0.05 mcg/Kg/min. Norepinephrine will be prepared as 8 mcg/mL and will be delivered using a syringe pump. Post-spinal hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection to delivery of the foetus) will be managed by IV ephedrine 9 mg. Severe post-spinal hypotension (defined as decreased SBP less than 60% of the baseline reading) will be managed by IV ephedrine 15 mg. Additional vasopressor bolus was given if SBP did not respond to the first dose within 2 minutes. Intraoperative hypertension (defined as SBP >120% of the baseline reading) will be managed by stopping norepinephrine infusion. The infusion will be resumed when blood pressure returned to its normal value. Intraoperative bradycardia (defined as heart rate less than 55 bpm without hypotension during the period from intrathecal injection to delivery of the fetus) will be managed by stopping the vasopressor infusion. If bradycardia was associated with hypotension, the patient was managed by IV ephedrine 9 mg. If bradycardia persisted after the previous measures, an IV atropine bolus (0.5 mg) will be given.
Norepinephrine total dose will be calculated in both groups for comparison purposes. Measurements will be taken every 2 minutes.
- Conditions
- Cesarean Section, Hypotension, Spinal Anaesthesia
- Being tested
- sitting position
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitting positionOther
patients will be left seated for 2 minutes after subarachnoid injection
| Study group | Role | What they receive |
|---|---|---|
| sitting position | Active comparator | patients will be left in the sitting position Receives: Other: sitting position |
| supine position | No intervention | patients will lie down immediately after injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
average systolic blood pressure
mmHg
Measured: immediately after SAB till delivery of fetus
Secondary outcomes (9)
post-spinal anaesthesia hypotension
frequency of patients with decreased systolic blood pressure less than 80% of the baseline reading
Measured: immediately after SAB till delivery of fetus
severe post-spinal anaesthesia hypotension
frequency of patients with decreased systolic blood pressure less than 60% of the baseline reading
Measured: immediately after SAB till delivery of fetus
reactive hypertension
percentage of patients with increased systolic blood pressure more than 120% of the baseline reading
Measured: immediately after SAB till delivery of fetus
nausea and vomiting
frequency
Measured: immediately after SAB till delivery of fetus
norepinephrine requirement
mcg
Measured: immediately after SAB till delivery of fetus
ephedrine requirement
mg
Measured: immediately after SAB till delivery of fetus
atropine requirement
mg
Measured: immediately after SAB till delivery of fetus
umbilical cord blood gases
pH
Measured: 1 minutes after delivery
Apgar score
assessing the appearance, pulse, grimace, activity, respiration on a scale from zero to two, then summing up the five values thus obtained. The resulting score ranges from zero to 10.
Measured: at 1 minute and 5 minutes post-delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Hasanin, Principal investigator, Cairo University Kasr Alainy Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777123
- Sponsor's protocol ID
- MD-85-2019
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data are not publicly available. Data are available from the authors upon reasonable request and after permission of Cairo university
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-spinal Anesthesia Hypotension in Caesarean Delivery Using Delayed Supine Positioning: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04777123
- Acronym / sponsor ID
- MD-85-2019
- Conditions
- Cesarean Section, Hypotension, Spinal Anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Mar 2021 (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.
Maternal hypotension is a common complication after spinal anaesthesia for caesarean delivery. Prophylaxis against post-spinal hypotension (PSH) during caesarean delivery would prevent serious maternal and fetal complications. Various methods had been investigated for prophylaxis against maternal hypotension. The basic components of management of PSH are: 1. Fluid loading. 2. Pharmacological agents. 3. Positioning protocols. Although Fluid loading is superior to non-loading protocols during caesarean delivery, the incidence of Post-spinal hypotension is high with all fluid loading protocols. Thus; the value of fluid loading in caesarean delivery could not be used solely for prevention of PSH. Using vasopressors for prophylaxis against PSH is nearly fundamental during caesarean delivery. However, vasopressors are not devoid of side effects such as reflex bradycardia after phenylephrine and fetal acidosis after ephedrine. Thus, combining vasopressor prophylaxis and non-pharmacological protocols would help to decrease the dose of vasopressors, and consequently decreasing their side effects. Ondansetron had been also reported as a useful prophylactic drug from PSH with minimal side effects. Positioning protocols, such as operating table tilting or flexing, the use of wedges or mechanical displacers, leg wrapping or sequential compression devices, head down and head up positioning aim to reversing aortocaval compression and/or increasing venous return. The sitting position for a short period after spinal block in order to slow the onset of the spinal block. Keeping the patient in the sitting position after spinal block would also prevent extension of local anaesthetic solution to upper thoracic dermatomes which is an important factor in preventing maternal hypotension.
no previous reports had evaluated the impact of sitting position within the context of a multimodal protocol for prophylaxis against maternal hypotension. In this study, we aim to evaluate the impact of 2-minute sitting position after spinal anesthesia on maternal hemodynamics when combined with prophylactic norepinephrine infusion plus preoperative bolus of ondansetron. We aim to reach the best possible maternal hemodynamic profile in addition to maintenance of adequate block level.
Detailed description
Upon arrival to operating room, Monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). All measurements will be taken before IV line insertion and premedications. Baseline systolic blood pressure will be obtained in the supine position as the mean of three consecutive readings at 2-minute intervals with a difference of less than 10%.
After insertion of a peripheral 18-gauge line with a three way valve for fluids and vasopressor infusion; Premedication's with ranitidine (50mg) and ondansetron (4 mg) will be administered. Subarachnoid block (SAB) will be done in sitting position under complete asepsis in L3-L4 or L4-L5 interspace using 25 g spinal needle. 11 mg of 0.5% intrathecal hyperbaric Bupivacaine and 25um fentanyl will be administered.
Block success will be assessed using pinprick or sensation to cold besides adequate motor block. Patients with failed SAB (Defined as sensory level below T4) will be excluded as well as patients with high spinal block (defined as spinal anaesthesia in which spinal denervation extends to second or third thoracic dermatome or sometimes up to cervical dermatomes).
Co-hydration will be continued up to a maximum of 1.5 litres (patients with intraoperative blood loss over 1000 ml will be excluded from the study). After delivery of the foetus, oxytocin will be given as an initial bolus of 0.5 IU over five seconds followed by 40 mIU/minute infusion. Inspired air will be supplemented with oxygen 3 l/min via a nasal catheter until delivery.
Continuous norepinephrine fixed rate infusion will be given to both groups as 5 mcg norepinephrine bolus at the same time cerebrospinal fluid obtained followed by norepinephrine infusion in a starting dose of 0.05 mcg/Kg/min. Norepinephrine will be prepared as 8 mcg/mL and will be delivered using a syringe pump. Post-spinal hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection to delivery of the foetus) will be managed by IV ephedrine 9 mg. Severe post-spinal hypotension (defined as decreased SBP less than 60% of the baseline reading) will be managed by IV ephedrine 15 mg. Additional vasopressor bolus was given if SBP did not respond to the first dose within 2 minutes. Intraoperative hypertension (defined as SBP >120% of the baseline reading) will be managed by stopping norepinephrine infusion. The infusion will be resumed when blood pressure returned to its normal value. Intraoperative bradycardia (defined as heart rate less than 55 bpm without hypotension during the period from intrathecal injection to delivery of the fetus) will be managed by stopping the vasopressor infusion. If bradycardia was associated with hypotension, the patient was managed by IV ephedrine 9 mg. If bradycardia persisted after the previous measures, an IV atropine bolus (0.5 mg) will be given.
Norepinephrine total dose will be calculated in both groups for comparison purposes. Measurements will be taken every 2 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sitting position | Active comparator | Other: sitting positionpatients will be left in the sitting position |
| supine position | No intervention | –patients will lie down immediately after injection |
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 (above 37 weeks gestation).
- Singleton.
- Pregnant woman ASA II scheduled for elective caesarean section aged between 18 and 35 years.
Key exclusion criteria (9 listed)
- Contraindications to spinal anaesthesia.
- Obese patients (body mass index >35).
- Peripartum bleeding.
- Impaired cardiac contractility (Ejection fraction<45%).
- Cardiac arrhythmias (I.e. any rhythm other than normal sinus rhythm and sinus tachycardia).
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 |
|---|---|---|
| sitting positionpatients will be left seated for 2 minutes after subarachnoid injection | Other | sitting position |
Primary outcome
average systolic blood pressure
Time frame: immediately after SAB till delivery of fetus
mmHg
9 secondary outcomes
post-spinal anaesthesia hypotension
Time frame: immediately after SAB till delivery of fetus
severe post-spinal anaesthesia hypotension
Time frame: immediately after SAB till delivery of fetus
reactive hypertension
Time frame: immediately after SAB till delivery of fetus
nausea and vomiting
Time frame: immediately after SAB till delivery of fetus
norepinephrine requirement
Time frame: immediately after SAB till delivery of fetus
ephedrine requirement
Time frame: immediately after SAB till delivery of fetus
atropine requirement
Time frame: immediately after SAB till delivery of fetus
umbilical cord blood gases
Time frame: 1 minutes after delivery
Apgar score
Time frame: at 1 minute and 5 minutes post-delivery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: Yes. The data are not publicly available. Data are available from the authors upon reasonable request and after permission of Cairo university
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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 Hasanin principal investigator
Cairo University Kasr Alainy Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sitting position in people with Cesarean Section and 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 3 inclusion and 9 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 2 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 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?
Contact Maha Mostafa, M.D (01000365115, maha.mostafa@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average systolic blood pressure (time frame: immediately after SAB till delivery of fetus). 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 2 Mar 2021.