Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension
Primary Purpose
Adverse Effect
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydroxyethyl starch
Crystalloid
Sponsored by
About this trial
This is an interventional treatment trial for Adverse Effect focused on measuring Crystalloid, Hydroxyethyl starch 130/0.4, Postspinal anesthesia hypotension, Cesarean section, Norepinephrine, Coload
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
Sites / Locations
- General Hospital of Ningxia Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hydroxyethyl starch coload group
Crystalloid coload group
Arm Description
10 ml/kg 6% Hydroxyethyl starch (130/0.4) 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
ED 50 and ED 90
The dose of prophylactic norepinephrine combined with 10 ml/kg 6% Hydroxyethyl starch (130/0.4) or 10 ml/kg crystalloid coload 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
NCT ID
NCT05475990
First Posted
July 25, 2022
Last Updated
March 20, 2023
Sponsor
General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05475990
Brief Title
Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension
Official Title
Comparison of 6% Hydroxyethyl Starch (130/0.4) and Crystalloid Coload Combined With Prophylactic Norepinephrine Infusion for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 21, 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 ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing 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. Colloid fluid 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. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Crystalloid, Hydroxyethyl starch 130/0.4, Postspinal anesthesia hypotension, Cesarean section, Norepinephrine, Coload
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxyethyl starch coload group
Arm Type
Experimental
Arm Description
10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia
Arm Title
Crystalloid coload group
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)
Hydroxyethyl starch
Other Intervention Name(s)
Colloid
Intervention Description
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.
Intervention Type
Drug
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
ED 50 and ED 90
Description
The dose of prophylactic norepinephrine combined with 10 ml/kg 6% Hydroxyethyl starch (130/0.4) or 10 ml/kg crystalloid coload 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 min after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
5 min after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
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
Xiangzhao Xu, M.D.; Ph. D
Organizational Affiliation
The People's Hospital of Nanchuan
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
12. IPD Sharing Statement
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Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension
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