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AnesthesiaNCT06231316

Preventing Hypotension in the Spine During Cesarean Delivery.

An observational study of Anesthesia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Examining the advantages associated with the utilization of noradrenaline in preventing spinal hypotension during cesarean births. This involves assessing the positive outcomes and potential benefits derived from incorporating noradrenaline into the medical approach. Read more about this study

Who is it for?
Ages 20 to 35 years, women only
Conditions the study is for
Anesthesia
What is being tested?
Norepinephrine Injection
Type of treatment
Injection or infusion
How many people
100 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 May 2025
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 20 to 35 years
  • Women only
  • Adult

Study population: Sample size was calculated using Epi- Info7. Based on Frequency of spinal hypotension decrease to 20% in patients received0.5_.10mg epinephrine ( put ref . ). With a confidence limits 5% and a confidence level of 90% the minimum patients required for this study is 173cases

Who may be able to join

  • The subject is scheduled for elective cesarean section .
  • No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.
  • ASA class 1-3.

Who cannot join

  • Patients have body mass index (BMI) >35 kg/m2. -Patients are known hypersensitivity to any of the drugs that would be used in the study. -
  • Severe cardiac, renal, lung, or liver diseases.
  • Eclampsia or preexisting hypertension (baseline systolic blood pressure ≥160 mmHg)
  • hemoglobin <7 g/dL, or fetal distress.
  • Patients that are immunologically compromised.
  • Sleep apnea syndrome or difficult airway. 8.preexisting hypoxemia (Spo2< 90 %).
  • Patient refusal.

About this study

Official title: Preventing Spinal Hypotension During Cesarean Birth With Two Initial Boluses of Norepinephrine

Examining the advantages associated with the utilization of noradrenaline in preventing spinal hypotension during cesarean births. This involves assessing the positive outcomes and potential benefits derived from incorporating noradrenaline into the medical approach.

Read the detailed description

Spinal anesthesia is used during cesarean section to provide rapid onset and dense block of motor and sensory nerves, intraoperative analgesia, and help patients remain conscious (1,2).Hypotension is common during induction of spinal anesthesia for cesarean delivery (CD) (3).If not promptly treated, a decrease in blood pressure (BP) can have deleterious effects, which include maternal nausea, vomiting, dizziness, and cardiovascular instability as well as decreased uteroplacental blood flow with resultant fetal acidosis, hypoxia, and bradycardia.In the last decade, the α-agonist phenylephrine (PE) has been the vasopressor of choice for the prevention and treatment of spinal induced hypotension (4).To prevent and treat postspinal anesthesia hypotension during cesarean section, vasopressors are recommended. Vasopressors (especially potent α-adrenergic receptor agonists) help offset the decrease in arteriolar dilation and peripheral vascular resistance caused by sympathetic nerve blockade after spinal anesthesia and may be associated with decreased incidence of neonatal acidosis.(5,6). Norepinephrine is another vasopressor that was recently introduced in obstetric anesthesia (7). Norepinephrine is characterized by α-adrenergic agonistic activity in addition to a weak β-adrenergic agonistic activity; thus, norepinephrine is considered a vasopressor with minimal cardiac depressant effect(7).; these pharmacologic properties would make norepinephrine an attractive alternative to phenylephrine and ephedrine in obstetric anesthesia. Although the use of norepinephrine for prophylaxis against postspinal hypotension has shown promising results,(7,8) evidence is lacking on the optimum dose for norepinephrine infusion during cesarean delivery.

Conditions
Anesthesia
Being tested
Norepinephrine Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Norepinephrine InjectionDrug

    Norepinephrine is both a neurotransmitter and a hormone. It is essential vasopressor for rapid blood pressure support, crucial in maintaining hemodynamic stability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The frequency of postspinal hypotension

    Assessment of how often blood pressure decreases following spinal anesthesia, crucial for proactive management in medical procedures.

    Measured: baseline

Secondary outcomes (1)

  1. Hemodynamic data

    the frequency of severe postspinal hypotension, frequency of postdelivery hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion), frequency of intraoperative nausea and vomiting, frequency of intraoperative hypertension.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231316
Sponsor's protocol ID
PSHDCB
Status last verified
Jan 2024
First submitted
20 Jan 2024
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.

    PubMed 25635593

  • Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018 Jun;126(6):1989-1994. doi: 10.1213/ANE.0000000000002243.

    PubMed 28678073

  • Sakata K, Yoshimura N, Tanabe K, Kito K, Nagase K, Iida H. Prediction of hypotension during spinal anesthesia for elective cesarean section by altered heart rate variability induced by postural change. Int J Obstet Anesth. 2017 Feb;29:34-38. doi: 10.1016/j.ijoa.2016.09.004. Epub 2016 Sep 22.

    PubMed 27789074

  • Kuhn JC, Hauge TH, Rosseland LA, Dahl V, Langesaeter E. Hemodynamics of Phenylephrine Infusion Versus Lower Extremity Compression During Spinal Anesthesia for Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Study. Anesth Analg. 2016 Apr;122(4):1120-9. doi: 10.1213/ANE.0000000000001174.

    PubMed 26991619

  • Macarthur A, Riley ET. Obstetric anesthesia controversies: vasopressor choice for postspinal hypotension during cesarean delivery. Int Anesthesiol Clin. 2007 Winter;45(1):115-32. doi: 10.1097/AIA.0b013e31802b8d53. No abstract available.

    PubMed 17215703

  • Lee JE, George RB, Habib AS. Spinal-induced hypotension: Incidence, mechanisms, prophylaxis, and management: Summarizing 20 years of research. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):57-68. doi: 10.1016/j.bpa.2017.01.001. Epub 2017 Jan 8.

    PubMed 28625306

  • Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.

    PubMed 31531852

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Assiut University.

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 7 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

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 frequency of postspinal hypotension (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231316, which also lists 7 linked publications.

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 30 Jan 2024.

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