6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 27, 2022
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2024
CompletedFebruary 2, 2024
January 1, 2024
3 months
July 25, 2022
January 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ED 50 and ED 90
The dose of 6% Hydroxyethyl starch (130/0.4) that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
1-15 minutes after spinal anesthesia
Secondary Outcomes (10)
The incidence of post-spinal anesthesia hypotension
1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension.
1-15 minutes after spinal anesthesia
The incidence of bradycardia.
1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.
1-15 minutes after spinal anesthesia
The incidence of hypertension.
1-15 minutes after spinal anesthesia
- +5 more secondary outcomes
Study Arms (1)
Hydroxyethyl starch (130/0.4) coload group
EXPERIMENTALAn initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia.
Interventions
An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 100 ml according to the responses of previous patients according to the up-down sequential allocation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yi Chen, M.D.
General Hospital of Ningxia Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 27, 2022
Study Start
February 1, 2024
Primary Completion
April 21, 2024
Study Completion
April 21, 2024
Last Updated
February 2, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share