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Not yet recruitingNCT07894783Updated Oct 26, 2026

ED90 of Norepinephrine and Phenylephrine Infusion in Patients of Advanced Maternal Age

An interventional study of Norepinephrine and Phenylephrine in Adverse Event and Hypotension (MeSH: D007022), sponsored by General Hospital of Ningxia Medical University. Not yet recruiting. Open to female participants aged 35 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 40 Years
Sex
Female
01

Study summary

This study aims to estimate the 90% effective dose (ED₉₀) of norepinephrine and phenylephrine infusions for the prevention of maternal hypotension in patients of advanced maternal age undergoing cesarean section, using the sequential allocation method.

Read the detailed description

The proportion of pregnancies involving advanced maternal age has been increasing annually, and advanced maternal age itself is an independent high-risk factor for maternal hypotension following spinal anesthesia for cesarean delivery. Therefore, theoretically, the demand for vasopressors during spinal anesthesia in advanced maternal age patients should be higher. This study aims to estimate the 90% effective dose (ED₉₀) of norepinephrine and phenylephrine infusions for the prevention of maternal hypotension in patients of advanced maternal age undergoing cesarean section, using the sequential allocation method.

02

Conditions studied

  • Adverse Event
  • Hypotension (MeSH: D007022)

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Keywords

  • Norepinephrine
  • Phenylephrine
  • Hypotension
  • Advanced maternal age
  • Cesarean section
03

In context

Hypotension

1,023 studies on the registry are indexed under Hypotension; 172 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 686 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 108 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 35-40 years
  • Full-term pregnancy
  • American Society of Anesthesiologists physical status classification II
  • Scheduled for cesarean section under spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • Body Mass Index ≥ 40 kg/m²;
  • Confirmed maternal cardiovascular disorders (including hypertensive disorders of pregnancy and preeclampsia) as well as fetal developmental abnormalities;
  • Fetal distress, or contraindications to spinal anesthesia including coagulation dysfunction and spinal malformations, etc.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Norepinephrine group

    The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

    Drug: Norepinephrine

  • Experimental
    Phenylephrine group

    The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

    Drug: Phenylephrine

Interventions

  • An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up down sequential allocation.

  • An initial infusion dose of prophylactic norepinephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up down sequential allocation.

06

What researchers measure

Primary outcomes

  1. ED90

    The ED90 of norepinephrine and phenylephrine infusion for prevention of maternal hypotension under spinal anesthesia

    Time frame: 1-15 minutes after spinal anesthesia

Secondary outcomes

  1. The incidence of post-spinal anesthesia hypotension

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

    Time frame: 1-15 minutes after spinal anesthesia.

  2. The incidence of severe post-spinal anesthesia hypotension.

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

    Time frame: 1-15 minutes after spinal anesthesia.

  3. pH

    From umbilical arterial blood gases.

    Time frame: Immediately after delivery

  4. APGAR score

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

    Time frame: 1 minute after delivery

  5. APGAR score

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

    Time frame: 5 minute after delivery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2027, 0 months later.

Of 237 non-industry interventional studies with no phase under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 25. This study's planned 0 months is below that.

Counting every sponsor, half of 248 studies reached it within 12 months; a quarter within 6 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartEst.
Jan 31, 2027
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07894783
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Jan 31, 2027 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Yi Chen
Contact
czzyxgp@163.com
86-951-674-3252
Yi Chen
principal investigator · General Hospital of Ningxia Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Norepinephrine · Phenylephrine

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