Clinical trial NCT05690334: Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine
Official title: Up-and-Down Determination of Different Crystalloid Coload Volumes on the 90% Effective Dose of Prophylactic Norepinephrine Infusions for Preventing Postspinal Anesthesia Hypotension During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect
Keywords: Norepinephrine
Postspinal anesthesia hypotension
Coload
Cesarean section
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing postspinal anesthesia hypotension during cesarean section.

Detailed 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. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

Eligibility criteria: 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

Primary outcomes:
measure: ED50 and ED90
timeFrame: 1-15 minutes after spinal anesthesia
Secondary outcomes:
measure: The incidence of post-spinal anesthesia hypotension
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of severe post-spinal anesthesia hypotension
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of bradycardia
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of nausea and vomiting
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of hypertension
timeFrame: 1-15 minutes after spinal anesthesia
measure: pH
timeFrame: Immediately after delivery
measure: Partial pressure of oxygen (PO2)
timeFrame: Immediately after delivery
measure: Base excess (BE)
timeFrame: Immediately after delivery
measure: APGAR score
timeFrame: 1 minute after delivery
measure: APGAR score
timeFrame: 5 minute after delivery
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Yi Chen, M.D.
role: STUDY_CHAIR
affiliation: The Fifth People's Hospital of Huaian
name: Xiangsheng Xiong, M.D.
role: STUDY_CHAIR
References: