Preventing Hypotension in the Spine During Cesarean Delivery.

Not yet recruiting

• Conditions: Anesthesia

• Registration Number: NCT06231316
• Lead Sponsor: Assiut University

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.

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-20
• Last Update Submitted: 2024-01-20
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Study Start: 2024-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of postspinal hypotension	baseline	Assessment of how often blood pressure decreases following spinal anesthesia, crucial for proactive management in medical procedures.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic data	baseline	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.