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

• Sponsor: General Hospital of Ningxia Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05712018
• Collaborator: (none)
• Enrollment: 120
• Arms: 3
• Anticipated Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: Hydroxyethyl starch coload - 0 ml/kg; Drug: Hydroxyethyl starch coload - 5 ml/kg; Drug: Hydroxyethyl starch coload - 10 ml/kg	N/A

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. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0 ml/kg Hydroxyethyl starch coload group No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia	Drug: Hydroxyethyl starch coload - 0 ml/kg; 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
Experimental: 5 ml/kg Hydroxyethyl starch coload group 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; 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
Experimental: 10 ml/kg Hydroxyethyl starch coload group 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; 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

Outcome Measures

Primary Outcome Measures

1. ED 50 [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 [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 Outcome Measures

1. The incidence of post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia]

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

2. The incidence of severe post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia]

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

3. The incidence of bradycardia [1-15 minutes after spinal anesthesia]

   Heart rate < 60 beats/min

4. The incidence of nausea and vomiting [1-15 minutes after spinal anesthesia]

   Presence of nausea and vomiting in patients after spinal anesthesia

5. The incidence of hypertension [1-15 minutes after spinal anesthesia]

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

6. pH [Immediately after delivery]

   From umbilical arterial blood gases

7. Partial pressure of oxygen (PO2) [Immediately after delivery]

   From umbilical arterial blood gases

8. Base excess (BE) [Immediately after delivery]

   From umbilical arterial blood gases

9. APGAR score [1 min after delivery]

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

10. APGAR score [5 min after delivery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• General Hospital of Ningxia Medical University

Investigators

• Study Chair: Yi Chen, M.D., General Hospital of Ningxia Medical University
• Study Chair: Xiangsheng Xiong, M.D., The Fifth People's Hospital of Huaian

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: General Hospital of Ningxia Medical University
• ClinicalTrials.gov Identifier: NCT05712018
• Other Study ID Numbers: Yi Chen-2023-1
• First Posted: Feb 3, 2023
• Last Update Posted: Feb 3, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by General Hospital of Ningxia Medical University: Norepinephrine; Hydroxyethyl starch 130/0.4; Postspinal anesthesia hypotension; Coload; Cesarean section
• Additional relevant MeSH terms: Hypotension; Hydroxyethyl Starch Derivatives

Study Results

No Results Posted as of Feb 3, 2023