NCT05133817

Brief Summary

The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal 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
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2022

Completed
Last Updated

September 7, 2022

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

November 12, 2021

Last Update Submit

September 5, 2022

Conditions

Adverse Event

Keywords

NorepinephrineHydroxyethyl starchPostspinal anesthesia hypotensionColoadCesarean section

Outcome Measures

Primary Outcomes (1)

  • The incidence of post-spinal anesthesia hypotension

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

    1-15 minutes after spinal anesthesia

Secondary Outcomes (10)

  • Overall stability of systolic blood pressure control versus baseline

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension.

    1-15 minutes after spinal anesthesia

  • The incidence of nausea and vomiting.

    1-15 minutes after spinal anesthesia

  • The incidence of bradycardia.

    1-15 minutes after spinal anesthesia

  • The incidence of hypertension.

    1-15 minutes after spinal anesthesia

  • +5 more secondary outcomes

Study Arms (5)

Control group

PLACEBO COMPARATOR

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.

Drug: Normal saline

0.025 μg/kg/min group

EXPERIMENTAL

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.025 μg/kg/min) by IV infusion.

Drug: Norepinephrine (0.025 μg/kg/min)

0.05 μg/kg/min group

EXPERIMENTAL

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.05 μg/kg/min) by IV infusion.

Drug: Norepinephrine (0.05 μg/kg/min)

0.075 μg/kg/min group

EXPERIMENTAL

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.075 μg/kg/min) by IV infusion.

Drug: Norepinephrine (0.075 μg/kg/min)

0.1μg/kg/min group

EXPERIMENTAL

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.1μg/kg/min) by IV infusion.

Drug: Norepinephrine (0.1 μg/kg/min)

Interventions

Normal salineDRUG

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.

Also known as: NS
Control group
Norepinephrine (0.025 μg/kg/min)DRUG

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.

Also known as: Vasopressor
0.025 μg/kg/min group
Norepinephrine (0.05 μg/kg/min)DRUG

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.

Also known as: Vasopressor
0.05 μg/kg/min group
Norepinephrine (0.075 μg/kg/min)DRUG

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.

Also known as: Vasopressor
0.075 μg/kg/min group
Norepinephrine (0.1 μg/kg/min)DRUG

Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.

Also known as: Vasopressor
0.1μg/kg/min 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, 75004, China

Location

Related Publications (1)

  • Guo L, Xiong X, Qin R, Li Z, Shi Y, Xue W, He L, Ma S, Chen Y. Prophylactic norepinephrine combined with 6% hydroxyethyl starch (130/0.4) co-load infusion for preventing postspinal anesthesia hypotension during cesarean section: a randomized, controlled, dose-finding trial. Daru. 2024 Jun;32(1):1-9. doi: 10.1007/s40199-023-00479-7. Epub 2023 Oct 9.

    PMID: 37812381DERIVED

MeSH Terms

Interventions

Saline SolutionNorepinephrineVasoconstrictor Agents

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Yi Chen, M.D.

    General Hospital of Ningxia Medical University

    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

November 12, 2021

First Posted

November 24, 2021

Study Start

November 26, 2021

Primary Completion

September 3, 2022

Study Completion

September 3, 2022

Last Updated

September 7, 2022

Record last verified: 2021-11

Locations

CN(1)