Prophylactic Norepinephrine Infusion Combined With Colloid Coloading for Postspinal Anesthesia Hypotension

September 5, 2022 updated by: General Hospital of Ningxia Medical University

Prophylactic Norepinephrine Infusion Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled, Dose-finding Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 75004
        • General Hospital of Ningxia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Criteria: 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group
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
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.
Other Names:
  • NS
Experimental: 0.025 μg/kg/min group
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)
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.
Other Names:
  • Vasopressor
Experimental: 0.05 μg/kg/min group
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)
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.
Other Names:
  • Vasopressor
Experimental: 0.075 μg/kg/min group
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)
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.
Other Names:
  • Vasopressor
Experimental: 0.1μg/kg/min group
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)
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.
Other Names:
  • Vasopressor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of post-spinal anesthesia hypotension
Time Frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 80% of the baseline
1-15 minutes after spinal anesthesia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall stability of systolic blood pressure control versus baseline
Time Frame: 1-15 minutes after spinal anesthesia
Evaluated by performance error (PE).
1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension.
Time Frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 60% of the baseline.
1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.
Time Frame: 1-15 minutes after spinal anesthesia
Presence of nausea and vomiting in patients after spinal anesthesia
1-15 minutes after spinal anesthesia
The incidence of bradycardia.
Time Frame: 1-15 minutes after spinal anesthesia
Heart rate < 55 beats/min.
1-15 minutes after spinal anesthesia
The incidence of hypertension.
Time Frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) >120% of the baseline.
1-15 minutes after spinal anesthesia
pH value
Time Frame: Immediately after fetal delivery
Analyse from umbilical arterial blood gases.
Immediately after fetal delivery
Partial pressure of oxygen
Time Frame: Immediately after fetal delivery
Analyse from umbilical arterial blood gases.
Immediately after fetal delivery
Concentration of base excess
Time Frame: Immediately after fetal delivery
Analyse from umbilical arterial blood gases.
Immediately after fetal delivery
Apgar score (0-10; a higher score means a better outcome)
Time Frame: 5 min after fetal delivery
A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
5 min after fetal delivery
Apgar score (0-10;a higher score means a better outcome)
Time Frame: 5 min after fetal delivery
A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
5 min after fetal delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Yi Chen-2021-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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