NCT05690334

Brief Summary

The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing postspinal anesthesia hypotension during cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

January 10, 2023

Last Update Submit

June 18, 2023

Conditions

Adverse Effect

Keywords

NorepinephrinePostspinal anesthesia hypotensionColoadCesarean section

Outcome Measures

Primary Outcomes (1)

  • ED50 and ED90

    The dose of prophylactic norepinephrine 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 (3)

Control group

EXPERIMENTAL

No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia

Drug: Crystalloid - 0 ml/kg

Crystalloid - 5 ml/kg

EXPERIMENTAL

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

Drug: Crystalloid - 5 ml/kg

Crystalloid - 10 ml/kg

EXPERIMENTAL

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

Drug: Crystalloid - 10 ml/kg

Interventions

Crystalloid - 0 ml/kgDRUG

No fluid coload was given. 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: Crystalloid
Control group
Crystalloid - 5 ml/kgDRUG

5 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.

Also known as: Crystalloid
Crystalloid - 5 ml/kg
Crystalloid - 10 ml/kgDRUG

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.

Also known as: Crystalloid
Crystalloid - 10 ml/kg

Eligibility Criteria

Age18 Years - 45 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 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 ≥180 mmHg
  • Hemoglobin \< 7g/dl
  • 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

Location

MeSH Terms

Interventions

Crystalloid Solutions

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yi Chen, M.D.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

  • Xiangsheng Xiong, M.D.

    The Fifth People's Hospital of Huaian

    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

January 10, 2023

First Posted

January 19, 2023

Study Start

March 21, 2023

Primary Completion

June 16, 2023

Study Completion

June 16, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

CN(1)