Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05475990

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: Hydroxyethyl starch Drug: Crystalloid	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. Colloid fluid 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. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of 6% Hydroxyethyl Starch (130/0.4) and Crystalloid Coload Combined With Prophylactic Norepinephrine Infusion for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hydroxyethyl starch coload group 500 ml 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia	Drug: Hydroxyethyl starch 500 ml 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 0.0025 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation. Other Names: Colloid
Experimental: Crystalloid coload group 500 ml crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.	Drug: Crystalloid 500 ml 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 0.0025 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Arm

Intervention/Treatment

Experimental: Hydroxyethyl starch coload group

500 ml 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia

Drug: Hydroxyethyl starch

500 ml 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 0.0025 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Other Names:

Colloid

Experimental: Crystalloid coload group

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

Drug: Crystalloid

500 ml 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 0.0025 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Outcome Measures

Primary Outcome Measures

ED 50 and ED 90 [1-15 minutes after spinal anesthesia]
The dose of prophylactic norepinephrine combined with 500 ml 6% Hydroxyethyl starch (130/0.4) or 500 ml crystalloid coload that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

Secondary Outcome Measures

The incidence of post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia]
Systolic blood pressure (SBP) < 80% of the baseline
The incidence of severe post-spinal anesthesia hypotension. [1-15 minutes after spinal anesthesia]
Systolic blood pressure (SBP) < 60% of the baseline.
The incidence of bradycardia. [1-15 minutes after spinal anesthesia]
Heart rate < 60 beats/min.
The incidence of nausea and vomiting. [1-15 minutes after spinal anesthesia]
Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of hypertension. [1-15 minutes after spinal anesthesia]
Systolic blood pressure (SBP) >120% of the baseline.
pH [Immediately after delivery]
From umbilical arterial blood gases.
Partial pressure of oxygen (PO2) [Immediately after delivery]
From umbilical arterial blood gases.
Base excess (BE) [Immediately after delivery]
From umbilical arterial blood gases.
APGAR score [1 min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
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 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

General Hospital of Ningxia Medical University

ClinicalTrials.gov Identifier:

NCT05475990

Other Study ID Numbers:

Yi Chen-2022-3

First Posted:

Jul 27, 2022

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by General Hospital of Ningxia Medical University

Crystalloid

Hydroxyethyl starch 130/0.4

Postspinal anesthesia hypotension

Cesarean section

Norepinephrine

Coload

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Jul 27, 2022