Adverse EffectNCT03997500
Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index
A study testing normal saline and Norepinephrine 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 preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Adverse Effect
- What is being tested?
- normal saline and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years
- American Society of Anesthesiologists physical status classification I to II
- Scheduled for elective cesarean delivery under spinal anesthesia
- Full-term, singleton, pregnant women
Who cannot join
- Height of no more than 150 centimeters
- Body weight greater than 100 kg or BMI greater than 30
- Labor analgesia had been performed
- Contraindication of spinal or epidural anesthesia
- Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg
- Hemoglobin <7g/dl
Show all 9Show fewer
- Fetal distress or known abnormal fetal development
- Severe vascular disease
- Diabetes mellitus or cardiovascular disease or nervous system disease
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).
Read the detailed description
Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).
- Conditions
- Adverse Effect
- Being tested
- normal saline, Norepinephrine
- Keywords
- Norepinephrine, Hypotension, Inferior Vena Cava Collapsibility Index, Cesarean Delivery
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
Also called NS
a bolus of normal saline was given followed by normal saline infusion
NorepinephrineDrug
Also called Vasopressors
a bolus of norepinephrine was given followed by norepinephrine infusion
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion Receives: Drug: normal saline |
| Norepinephrine | Experimental | Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypotension
SBP decreased to <80% of the baseline value
Measured: 1 to 20 minutes after subarachnoid block
Inferior vena cava collapsibility index
CI = (dIVCmax - dIVCmin)/dIVCmax
Measured: 5 to 20 minutes after subarachnoid block
Secondary outcomes (10)
The incidence of nausea and vomiting
Presence of nausea and vomiting in patients after subarachnoid block
Measured: 1 to 20 minutes after subarachnoid block
The incidence of bradycardia
Heart rate less than 55 bpm
Measured: 1 to 20 minutes after subarachnoid block
Incidence of hypertension
Systolic blood pressure at or above 120% of baseline
Measured: 1 to 20 minutes after subarachnoid block
Arterial base excess of fetal vein blood
From umbilical vein blood gases
Measured: Immediately after delivery
Pressure of oxygen of fetal vein blood
From umbilical vein blood gases
Measured: Immediately after delivery
pH value of fetal vein blood
From umbilical vein blood gases
Measured: Immediately after delivery
Number of rescue norepinephrine
a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value
Measured: Immediately to 20 minutes after subarachnoid block
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 1min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 5min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 10min after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jan 2019
- Primary completion21 Oct 2019
- Study completion31 Dec 2019
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinli Ni, Dr., Study chair, xinlini6@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997500
- Sponsor's protocol ID
- Yi Chen
- Status last verified
- May 2019
- First submitted
- 28 May 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT03997500
- Acronym / sponsor ID
- Yi Chen
- Conditions
- Adverse Effect
- Keywords
- Norepinephrine, Hypotension, Inferior Vena Cava Collapsibility Index, Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Jun 2019 (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 preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).
Detailed description
Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: normal salineSimultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion |
| Norepinephrine | Experimental | Drug: NorepinephrineSimultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-45 years
- American Society of Anesthesiologists physical status classification I to II
- Scheduled for elective cesarean delivery under spinal anesthesia
- Full-term, singleton, pregnant women
Key exclusion criteria (9 listed)
- Height of no more than 150 centimeters
- Body weight greater than 100 kg or BMI greater than 30
- Labor analgesia had been performed
- Contraindication of spinal or epidural anesthesia
- Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg
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: NSa bolus of normal saline was given followed by normal saline infusion | Drug | Normal saline |
| NorepinephrineAlso: Vasopressorsa bolus of norepinephrine was given followed by norepinephrine infusion | Drug | Norepinephrine |
Primary outcome
The incidence of hypotension
Time frame: 1 to 20 minutes after subarachnoid block
SBP decreased to <80% of the baseline value
Inferior vena cava collapsibility index
Time frame: 5 to 20 minutes after subarachnoid block
CI = (dIVCmax - dIVCmin)/dIVCmax
10 secondary outcomes
The incidence of nausea and vomiting
Time frame: 1 to 20 minutes after subarachnoid block
The incidence of bradycardia
Time frame: 1 to 20 minutes after subarachnoid block
Incidence of hypertension
Time frame: 1 to 20 minutes after subarachnoid block
Arterial base excess of fetal vein blood
Time frame: Immediately after delivery
Pressure of oxygen of fetal vein blood
Time frame: Immediately after delivery
pH value of fetal vein blood
Time frame: Immediately after delivery
Number of rescue norepinephrine
Time frame: Immediately to 20 minutes after subarachnoid block
APGAR score
Time frame: 1min after delivery
APGAR score
Time frame: 5min after delivery
APGAR score
Time frame: 10min 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 17 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Xinli Ni, Dr. study chair
xinlini6@yahoo.com
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 and Norepinephrine 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 4 inclusion and 9 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 17 Feb 2020. 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 hypotension (time frame: 1 to 20 minutes after subarachnoid block). The study lists 2 primary outcomes in all. 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 17 Feb 2020.