NCT05475990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

March 22, 2023

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 25, 2022

Last Update Submit

March 20, 2023

Conditions

Adverse Effect

Keywords

CrystalloidHydroxyethyl starch 130/0.4Postspinal anesthesia hypotensionCesarean sectionNorepinephrineCoload

Outcome Measures

Primary Outcomes (1)

  • 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

    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 (2)

Hydroxyethyl starch coload group

EXPERIMENTAL

10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia

Drug: Hydroxyethyl starch

Crystalloid coload group

EXPERIMENTAL

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

Drug: Crystalloid

Interventions

Hydroxyethyl starchDRUG

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.

Also known as: Colloid
Hydroxyethyl starch coload group
CrystalloidDRUG

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.

Crystalloid coload group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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, China

Location

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesColloidsCrystalloid Solutions

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesComplex MixturesDosage FormsPharmaceutical PreparationsIsotonic SolutionsSolutions

Study Officials

  • Yi Chen, M.D.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

  • Xiangzhao Xu, M.D.; Ph. D

    The People's Hospital of Nanchuan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 27, 2022

Study Start

January 11, 2023

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

March 22, 2023

Record last verified: 2022-07

Locations

CN(1)