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Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine

Primary Purpose

Adverse Effect

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Crystalloid - 0 ml/kg
Crystalloid - 5 ml/kg
Crystalloid - 10 ml/kg
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Effect focused on measuring Norepinephrine, Postspinal anesthesia hypotension, Coload, Cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control group

Crystalloid - 5 ml/kg

Crystalloid - 10 ml/kg

Arm Description

No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia

5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.

10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.

Outcomes

Primary Outcome Measures

ED50 and ED90
The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

Secondary Outcome Measures

The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
The incidence of severe post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 60% of the baseline
The incidence of bradycardia
Heart rate < 60 beats/min
The incidence of nausea and vomiting
Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of hypertension
Systolic blood pressure (SBP) >120% of the baseline
pH
From umbilical arterial blood gases
Partial pressure of oxygen (PO2)
From umbilical arterial blood gases
Base excess (BE)
From umbilical arterial blood gases
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Full Information

First Posted
January 10, 2023
Last Updated
June 18, 2023
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05690334
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Norepinephrine, Postspinal anesthesia hypotension, Coload, Cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia
Arm Title
Crystalloid - 5 ml/kg
Arm Type
Experimental
Arm Description
5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
Arm Title
Crystalloid - 10 ml/kg
Arm Type
Experimental
Arm Description
10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
Crystalloid - 0 ml/kg
Other Intervention Name(s)
Crystalloid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Crystalloid - 5 ml/kg
Other Intervention Name(s)
Crystalloid
Intervention Description
5 ml/kg crystalloid 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.
Intervention Type
Drug
Intervention Name(s)
Crystalloid - 10 ml/kg
Other Intervention Name(s)
Crystalloid
Intervention Description
10 ml/kg crystalloid 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.
Primary Outcome Measure Information:
Title
ED50 and ED90
Description
The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
Time Frame
1-15 minutes after spinal anesthesia
Secondary Outcome Measure Information:
Title
The incidence of post-spinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 80% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of severe post-spinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 60% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of bradycardia
Description
Heart rate < 60 beats/min
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of nausea and vomiting
Description
Presence of nausea and vomiting in patients after spinal anesthesia
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of hypertension
Description
Systolic blood pressure (SBP) >120% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Title
pH
Description
From umbilical arterial blood gases
Time Frame
Immediately after delivery
Title
Partial pressure of oxygen (PO2)
Description
From umbilical arterial blood gases
Time Frame
Immediately after delivery
Title
Base excess (BE)
Description
From umbilical arterial blood gases
Time Frame
Immediately after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
1 minute after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
5 minute after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Chen, M.D.
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiangsheng Xiong, M.D.
Organizational Affiliation
The Fifth People's Hospital of Huaian
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

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Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine

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