Comparison of Different HES Coload Volumes on the 90% ED of Norepinephrine

Adverse Effect Clinical Trial

Official title:

Comparison of Different 6% Hydroxyethyl Starch (130/0.4) Coload Volumes on the 90% Effective Dose of Norepinephrine Infusion Prophylaxis for Hypotension During Spinal Anesthesia for Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712018
• Other study ID #: Yi Chen-2023-1
• Status: Completed
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: January 23, 2024

Study information

• Verified date: January 2024
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for 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. 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 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 23, 2024
• Est. primary completion date: January 23, 2024
• 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

Related Conditions & MeSH terms

• Adverse Effect
• Hypotension

Intervention

Drug:
• Hydroxyethyl starch coload - 0 ml/kg
No fluid coload was given. An initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
• Hydroxyethyl starch coload - 5 ml/kg
5 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
• Hydroxyethyl starch coload - 10 ml/kg
10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

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