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Completed

NCT Number: NCT05712018

Comparison of Different HES Coload Volumes on the 90% ED of Norepinephrine

The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

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. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-45 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

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 ≥180 mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Treatment and study plan

Hydroxyethyl starch coload - 0 ml/kg

Drug

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.

Other names: Colloid

Hydroxyethyl starch coload - 5 ml/kg

Drug

5 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.

Other names: Colloid

Hydroxyethyl starch coload - 10 ml/kg

Drug

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.

Other names: Colloid

Primary outcomes

  1. ED 50

    Time frame: 1-15 minutes after spinal anesthesia

    The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) of patients

  2. ED 90

    Time frame: 1-15 minutes after spinal anesthesia

    The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 90% (ED90) of patients

Secondary outcomes

  1. The incidence of post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

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

  2. The incidence of severe post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

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

  3. The incidence of bradycardia

    Time frame: 1-15 minutes after spinal anesthesia

    Heart rate < 60 beats/min

  4. The incidence of nausea and vomiting

    Time frame: 1-15 minutes after spinal anesthesia

    Presence of nausea and vomiting in patients after spinal anesthesia

  5. The incidence of hypertension

    Time frame: 1-15 minutes after spinal anesthesia

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

  6. pH

    Time frame: Immediately after delivery

    From umbilical arterial blood gases

  7. Partial pressure of oxygen (PO2)

    Time frame: Immediately after delivery

    From umbilical arterial blood gases

  8. Base excess (BE)

    Time frame: Immediately after delivery

    From umbilical arterial blood gases

  9. APGAR score

    Time frame: 1 min after delivery

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

  10. APGAR score

    Time frame: 5 min after delivery

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

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Comparison of Different 6% Hydroxyethyl Starch (130/0.4) Coload Volumes on the 90% Effective Dose of Norepinephrine Infusion Prophylaxis for Hypotension During Spinal Anesthesia for Cesarean Section

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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