Preventing Hypotension in the Spine During Cesarean Delivery.

NCT06231316 | Unknown

• 1 other identifier: PSHDCB
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• The frequency of postspinal hypotension

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

  baseline

Secondary Outcomes (1)

• Hemodynamic data

  baseline

Interventions

Norepinephrine Injection DRUG

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

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 25635593 BACKGROUND

• 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.

  PMID: 28678073 BACKGROUND

• 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.

  PMID: 27789074 BACKGROUND

• 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.

  PMID: 26991619 BACKGROUND

• 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.

  PMID: 17215703 BACKGROUND

• 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.

  PMID: 28625306 BACKGROUND

• 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.

  PMID: 31531852 BACKGROUND

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 30, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01