Preventing Hypotension in the Spine During Cesarean Delivery.

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06231316
• Other study ID #: PSHDCB
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• The subject is scheduled for elective cesarean section .

• No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.

• ASA class 1-3.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anesthesia
• Hypotension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Anesth Analg. 2019 Apr;128(4):e60. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of postspinal hypotension	Assessment of how often blood pressure decreases following spinal anesthesia, crucial for proactive management in medical procedures.	baseline
Secondary	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.	baseline