Prophylactic Norepinephrine Infusion Combined With Colloid Coloading for Postspinal Anesthesia Hypotension

Adverse Event Clinical Trial

Official title:

Prophylactic Norepinephrine Infusion Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled, Dose-finding Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133817
• Other study ID #: Yi Chen-2021-5
• Status: Completed
• Phase: N/A
• Start date: November 26, 2021
• Est. completion date: September 3, 2022

Study information

• Verified date: November 2021
• 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 suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing 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. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: September 3, 2022
• Est. primary completion date: September 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Criteria: Inclusion Criteria:

• 18-40 years
• Primipara or multipara
• Singleton pregnancy = 37 weeks
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for elective 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 = 160mmHg
• Hemoglobin < 7g/dl
• Coagulation or renal function disorders
• Known allergy to hydroxyethyl starch
• Fetal distress, or known fetal developmental anomaly

Related Conditions & MeSH terms

• Adverse Event
• Hypotension

Intervention

Drug:
• Normal saline
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.
• Norepinephrine (0.025 µg/kg/min)
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
• Norepinephrine (0.05 µg/kg/min)
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
• Norepinephrine (0.075 µg/kg/min)
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
• Norepinephrine (0.1 µg/kg/min)
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.

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	The incidence of post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	1-15 minutes after spinal anesthesia
Secondary	Overall stability of systolic blood pressure control versus baseline	Evaluated by performance error (PE).	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 nausea and vomiting.	Presence of nausea and vomiting in patients after spinal anesthesia	1-15 minutes after spinal anesthesia
Secondary	The incidence of bradycardia.	Heart rate < 55 beats/min.	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 value	Analyse from umbilical arterial blood gases.	Immediately after fetal delivery
Secondary	Partial pressure of oxygen	Analyse from umbilical arterial blood gases.	Immediately after fetal delivery
Secondary	Concentration of base excess	Analyse from umbilical arterial blood gases.	Immediately after fetal delivery
Secondary	Apgar score (0-10; a higher score means a better outcome)	A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)	5 min after fetal delivery
Secondary	Apgar score (0-10;a higher score means a better outcome)	A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)	5 min after fetal delivery