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6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05475886
Collaborator
(none)
40
Enrollment
1
Arm
3.9
Anticipated Duration (Months)

Study Details

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) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydroxyethyl starch 130/0.4
 N/A

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. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension are still unknown. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydroxyethyl starch (130/0.4) coload group

An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia.

Drug: Hydroxyethyl starch 130/0.4
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.
Other Names:
  • Colloid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ED 50 and ED 90 [1-15 minutes after spinal anesthesia]

      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

    Secondary Outcome Measures

    1. The incidence of post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia]

      Systolic blood pressure (SBP) < 80% of the baseline

    2. The incidence of severe post-spinal anesthesia hypotension. [1-15 minutes after spinal anesthesia]

      Systolic blood pressure (SBP) < 60% of the baseline.

    3. The incidence of bradycardia. [1-15 minutes after spinal anesthesia]

      Heart rate < 60 beats/min.

    4. The incidence of nausea and vomiting. [1-15 minutes after spinal anesthesia]

      Presence of nausea and vomiting in patients after spinal anesthesia

    5. The incidence of hypertension. [1-15 minutes after spinal anesthesia]

      Systolic blood pressure (SBP) >120% of the baseline.

    6. pH [Immediately after delivery]

      From umbilical arterial blood gases.

    7. Partial pressure of oxygen (PO2) [Immediately after delivery]

      From umbilical arterial blood gases.

    8. Base excess (BE) [Immediately after delivery]

      From umbilical arterial blood gases.

    9. APGAR score [1 min after delivery]

      A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    10. APGAR score [5 min after delivery]

      A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • General Hospital of Ningxia Medical University

    Investigators

    • Study Chair: Yi Chen, M.D., General Hospital of Ningxia Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Hospital of Ningxia Medical University
    ClinicalTrials.gov Identifier:
    NCT05475886
    Other Study ID Numbers:
    • Yi Chen-2022-2
    First Posted:
    Jul 27, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by General Hospital of Ningxia Medical University
    Hydroxyethyl starch 130/0.4
    Coload
    Hypotension
    Cesarean section
    Additional relevant MeSH terms:
    Hypotension
    Hydroxyethyl Starch Derivatives

    Study Results

    No Results Posted as of Jul 27, 2022