Adverse EffectNCT05475990
Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension
A study testing Hydroxyethyl starch and Crystalloid in people with Adverse Effect, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Adverse Effect
- What is being tested?
- Hydroxyethyl starch and Crystalloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2023to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Adverse Effect
- Being tested
- Hydroxyethyl starch, Crystalloid
- Keywords
- Crystalloid, Hydroxyethyl starch 130/0.4, Postspinal anesthesia hypotension, Cesarean section, Norepinephrine, Coload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl starchDrug
Also called Colloid
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.
CrystalloidDrug
10 ml/kg 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 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Hydroxyethyl starch |
| Crystalloid coload group | Experimental | 10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia. Receives: Drug: Crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED 50 and ED 90
The dose of prophylactic norepinephrine combined with 10 ml/kg 6% Hydroxyethyl starch (130/0.4) or 10 ml/kg crystalloid coload that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
Measured: 1-15 minutes after spinal anesthesia
Secondary outcomes (10)
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
Measured: 1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) < 60% of the baseline.
Measured: 1-15 minutes after spinal anesthesia
The incidence of bradycardia.
Heart rate < 60 beats/min.
Measured: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
Measured: 1-15 minutes after spinal anesthesia
The incidence of hypertension.
Systolic blood pressure (SBP) >120% of the baseline.
Measured: 1-15 minutes after spinal anesthesia
pH
From umbilical arterial blood gases.
Measured: Immediately after delivery
Partial pressure of oxygen (PO2)
From umbilical arterial blood gases.
Measured: Immediately after delivery
Base excess (BE)
From umbilical arterial blood gases.
Measured: Immediately after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 1 min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 5 min after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start11 Jan 2023
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Chen, M.D., Study chair, General Hospital of Ningxia Medical UniversityXiangzhao Xu, M.D.; Ph. D, Study chair, The People's Hospital of Nanchuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475990
- Sponsor's protocol ID
- Yi Chen-2022-3
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05475990
- Acronym / sponsor ID
- Yi Chen-2022-3
- Conditions
- Adverse Effect
- Keywords
- Crystalloid, Hydroxyethyl starch 130/0.4, Postspinal anesthesia hypotension, Cesarean section, Norepinephrine, Coload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxyethyl starch coload group | Experimental | Drug: Hydroxyethyl starch10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia |
| Crystalloid coload group | Experimental | Drug: Crystalloid10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethyl starchAlso: Colloid10 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. | Drug | Hydroxyethyl starch coload group |
| Crystalloid10 ml/kg 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 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation. | Drug | Crystalloid coload group |
Primary outcome
ED 50 and ED 90
Time frame: 1-15 minutes after spinal anesthesia
The dose of prophylactic norepinephrine combined with 10 ml/kg 6% Hydroxyethyl starch (130/0.4) or 10 ml/kg crystalloid coload that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
10 secondary outcomes
The incidence of post-spinal anesthesia hypotension
Time frame: 1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of bradycardia.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension.
Time frame: 1-15 minutes after spinal anesthesia
pH
Time frame: Immediately after delivery
Partial pressure of oxygen (PO2)
Time frame: Immediately after delivery
Base excess (BE)
Time frame: Immediately after delivery
APGAR score
Time frame: 1 min after delivery
APGAR score
Time frame: 5 min after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Chen, M.D. study chair
General Hospital of Ningxia Medical University
Xiangzhao Xu, M.D.; Ph. D study chair
The People's Hospital of Nanchuan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyethyl starch and Crystalloid in people with Adverse Effect, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED 50 and ED 90 (time frame: 1-15 minutes after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.