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

NCT05712018 | Completed

• 1 other identifier: Yi Chen-2023-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adverse Effect

Keywords

Norepinephrine; Hydroxyethyl starch 130/0.4; Postspinal anesthesia hypotension; Coload; Cesarean section

Outcome Measures

Primary Outcomes (2)

• ED 50

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

  1-15 minutes after spinal anesthesia

• ED 90

  The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 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

Study Arms (3)

0 ml/kg Hydroxyethyl starch coload group

EXPERIMENTAL

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

Drug: Hydroxyethyl starch coload - 0 ml/kg

5 ml/kg Hydroxyethyl starch coload group

EXPERIMENTAL

5 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 coload - 5 ml/kg

10 ml/kg 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 coload - 10 ml/kg

Interventions

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.

Also known as: Colloid

0 ml/kg Hydroxyethyl starch coload group

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.

Also known as: Colloid

5 ml/kg Hydroxyethyl starch coload group

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.

Also known as: Colloid

10 ml/kg Hydroxyethyl starch coload group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Colloids

Intervention Hierarchy (Ancestors)

Complex Mixtures; Dosage Forms; Pharmaceutical 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: February 3, 2023
• Study Start: October 20, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

CN (1)