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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06158048
Other study ID # Yi Chen-2024-9
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2025
Est. completion date March 30, 2025

Study information

Verified date November 2023
Source General Hospital of Ningxia Medical University
Contact Yi Chen, M.D.
Phone 86-951-674-3252
Email czzyxgp@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment during cesarean section


Description:

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment during cesarean section


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 18-45 years - Primipara or multipara - Singleton pregnancy =37 weeks - American Society of Anesthesiologists physical status classification I to II - Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: - Body height < 150 cm - Body weight > 100 kg or body mass index (BMI) = 40 kg/m2 - Eclampsia or chronic hypertension or baseline blood pressure =180 mmHg - Hemoglobin < 7g/dl - Fetal distress, or known fetal developmental anomaly

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Norepinephrine
An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Phenylephrine
An initial infusion dose of prophylactic phenylephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Ningxia Medical University

Outcome

Type Measure Description Time frame Safety issue
Other The incidence of severe post-spinal anesthesia hypotension. Systolic blood pressure (SBP) < 60% of the baseline. 1-15 minutes after spinal anesthesia
Other The incidence of bradycardia. Heart rate < 60 beats/min. 1-15 minutes after spinal anesthesia
Other The incidence of nausea and vomiting. Presence of nausea and vomiting in patients after spinal anesthesia 1-15 minutes after spinal anesthesia
Other The incidence of hypertension. Systolic blood pressure (SBP) >120% of the baseline. 1-15 minutes after spinal anesthesia
Other pH From umbilical arterial blood gases. Immediately after delivery
Other Base excess From umbilical arterial blood gases. Immediately after delivery
Other Partial pressure of oxygen (PO2) From umbilical arterial blood gases. Immediately after delivery
Other APGAR score A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best) 1 min after delivery
Other APGAR score A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best) 5 min after delivery
Primary ED50 and ED90 The doses of prophylactic norepinephrine and phenylephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients 1-15 minutes after spinal anesthesia
Secondary The incidence of post-spinal anesthesia hypotension Systolic blood pressure (SBP) < 80% of the baseline 1-15 minutes after spinal anesthesia
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