Adverse EventNCT05133817
Prophylactic Norepinephrine Infusion Combined With Colloid Coloading for Postspinal Anesthesia Hypotension
A study testing Normal saline, Norepinephrine (0.025 μg/kg/min) and Norepinephrine (0.05 μg/kg/min) in people with Adverse Event, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal 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 Event
- What is being tested?
- Normal saline, Norepinephrine (0.025 μg/kg/min) and Norepinephrine (0.05 μg/kg/min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2021to 3 Sep 2022
- 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
None listed.
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.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 75004
About this study
Official title: Prophylactic Norepinephrine Infusion Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled, Dose-finding Trial
The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal 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. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.
- Conditions
- Adverse Event
- Being tested
- Normal saline, Norepinephrine (0.025 μg/kg/min), Norepinephrine (0.05 μg/kg/min), Norepinephrine (0.075 μg/kg/min), Norepinephrine (0.1 μg/kg/min)
- Keywords
- Norepinephrine, Hydroxyethyl starch, Postspinal anesthesia hypotension, Coload, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called NS
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.
Norepinephrine (0.025 μg/kg/min)Drug
Also called Vasopressor
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Norepinephrine (0.05 μg/kg/min)Drug
Also called Vasopressor
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Norepinephrine (0.075 μg/kg/min)Drug
Also called Vasopressor
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Norepinephrine (0.1 μg/kg/min)Drug
Also called Vasopressor
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion. Receives: Drug: Normal saline |
| 0.025 μg/kg/min group | Experimental | Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.025 μg/kg/min) by IV infusion. Receives: Drug: Norepinephrine (0.025 μg/kg/min) |
| 0.05 μg/kg/min group | Experimental | Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.05 μg/kg/min) by IV infusion. Receives: Drug: Norepinephrine (0.05 μg/kg/min) |
| 0.075 μg/kg/min group | Experimental | Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.075 μg/kg/min) by IV infusion. Receives: Drug: Norepinephrine (0.075 μg/kg/min) |
| 0.1μg/kg/min group | Experimental | Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.1μg/kg/min) by IV infusion. Receives: Drug: Norepinephrine (0.1 μg/kg/min) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
Measured: 1-15 minutes after spinal anesthesia
Secondary outcomes (10)
Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE).
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 nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
Measured: 1-15 minutes after spinal anesthesia
The incidence of bradycardia.
Heart rate < 55 beats/min.
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 value
Analyse from umbilical arterial blood gases.
Measured: Immediately after fetal delivery
Partial pressure of oxygen
Analyse from umbilical arterial blood gases.
Measured: Immediately after fetal delivery
Concentration of base excess
Analyse from umbilical arterial blood gases.
Measured: Immediately after fetal delivery
Apgar score (0-10; a higher score means a better outcome)
A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
Measured: 5 min after fetal delivery
Apgar score (0-10;a higher score means a better outcome)
A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
Measured: 5 min after fetal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start26 Nov 2021
- Primary completion3 Sep 2022
- Study completion3 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse EventStudies 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
- 175 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133817
- Sponsor's protocol ID
- Yi Chen-2021-5
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo L, Xiong X, Qin R, Li Z, Shi Y, Xue W, He L, Ma S, Chen Y. Prophylactic norepinephrine combined with 6% hydroxyethyl starch (130/0.4) co-load infusion for preventing postspinal anesthesia hypotension during cesarean section: a randomized, controlled, dose-finding trial. Daru. 2024 Jun;32(1):1-9. doi: 10.1007/s40199-023-00479-7. Epub 2023 Oct 9.
PubMed 37812381
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Norepinephrine Infusion Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled, Dose-finding Trial
- ClinicalTrials.gov ID
- NCT05133817
- Acronym / sponsor ID
- Yi Chen-2021-5
- Conditions
- Adverse Event
- Keywords
- Norepinephrine, Hydroxyethyl starch, Postspinal anesthesia hypotension, Coload, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 3 Sep 2022 (actual)
- Study completion
- 3 Sep 2022 (actual)
- First posted
- 24 Nov 2021 (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 suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal 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. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal 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
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Normal salineSimultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion. |
| 0.025 μg/kg/min group | Experimental | Drug: Norepinephrine (0.025 μg/kg/min)Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.025 μg/kg/min) by IV infusion. |
| 0.05 μg/kg/min group | Experimental | Drug: Norepinephrine (0.05 μg/kg/min)Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.05 μg/kg/min) by IV infusion. |
| 0.075 μg/kg/min group | Experimental | Drug: Norepinephrine (0.075 μg/kg/min)Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.075 μg/kg/min) by IV infusion. |
| 0.1μg/kg/min group | Experimental | Drug: Norepinephrine (0.1 μg/kg/min)Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.1μg/kg/min) by IV infusion. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
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 |
|---|---|---|
| Normal salineAlso: NSSimultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion. | Drug | Control group |
| Norepinephrine (0.025 μg/kg/min)Also: VasopressorSimultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion. | Drug | 0.025 μg/kg/min group |
| Norepinephrine (0.05 μg/kg/min)Also: VasopressorSimultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion. | Drug | 0.05 μg/kg/min group |
| Norepinephrine (0.075 μg/kg/min)Also: VasopressorSimultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion. | Drug | 0.075 μg/kg/min group |
| Norepinephrine (0.1 μg/kg/min)Also: VasopressorSimultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion. | Drug | 0.1μg/kg/min group |
Primary outcome
The incidence of post-spinal anesthesia hypotension
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 80% of the baseline
10 secondary outcomes
Overall stability of systolic blood pressure control versus baseline
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 nausea and vomiting.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of bradycardia.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension.
Time frame: 1-15 minutes after spinal anesthesia
pH value
Time frame: Immediately after fetal delivery
Partial pressure of oxygen
Time frame: Immediately after fetal delivery
Concentration of base excess
Time frame: Immediately after fetal delivery
Apgar score (0-10; a higher score means a better outcome)
Time frame: 5 min after fetal delivery
Apgar score (0-10;a higher score means a better outcome)
Time frame: 5 min after fetal 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 7 Sep 2022.
- Derived from this study: PubMed 37812381Guo L, Xiong X, Qin R, Li Z, Shi Y, Xue W, He L, Ma S, Chen Y. Prophylactic norepinephrine combined with 6% hydroxyethyl starch (130/0.4) co-load infusion for preventing postspinal anesthesia hypotension during cesarean section: a randomized, controlled, dose-finding trial. Daru. 2024 Jun;32(1):1-9. doi: 10.1007/s40199-023-00479-7. Epub 2023 Oct 9.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline, Norepinephrine (0.025 μg/kg/min) and Norepinephrine (0.05 μg/kg/min) in people with Adverse Event, 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 0 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 7 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
The incidence of post-spinal anesthesia hypotension (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?
On the ClinicalTrials.gov record for NCT05133817, which also lists 1 linked publication.
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 7 Sep 2022.