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NCT07327320: NORPHE-CD
Norepinephrine vs. Phenylephrine for Hypotension in Low-Dose Spinal Anesthesia for Cesarean Delivery
Phase 4 trial testing Norepinephrine in Anesthesia in 100 participants. Completed in 4 October 2025.
4 October 2025
Quick facts
| Lead sponsor | Tam Anh Research Institute |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 6 June 2024 |
| Primary completion | 4 October 2025 |
| Estimated completion | 4 October 2025 |
| Sites | 1 location across Vietnam |
Drugs / interventions tested
- Norepinephrine (NOREPINEPHRINE) — full drug profile →
- Phenylephrine (phenylephrine) — full drug profile →
Conditions studied
- Anesthesia — all drugs for Anesthesia →
- Spinal — all drugs for Spinal →
- Cesarean Section — all drugs for Cesarean Section →
- Hypotension, Controlled — all drugs for Hypotension, Controlled →
Sponsor
Tam Anh Research Institute
Who can join
18 and older, female only, with Anesthesia or Spinal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial was conducted to compare the effectiveness and safety of two medications, norepinephrine and phenylephrine, in preventing hypotension during low-dose spinal anesthesia for cesarean delivery (CD). Although low-dose spinal anesthesia combined with opioids is widely used to mitigate hypotension, the incidence remains unacceptably high. Thus, vasopressors remain essential in maintaining maternal blood pressure during these procedures. In this study, 100 women were initially assessed, with 2 excluded. The remaining 98 were randomly assigned to receive a continuous infusion of either norepinephrine or phenylephrine. During the follow-up process, 2 patients from each group were lost, resulting in 47 participants per group for final analysis. The results showed that norepinephrine was significantly more effective, with a lower incidence of hypotension (14.9% vs. 42.6%). It also provided more stable heart rates with fewer episodes of bradycardia and less need for rescue medications. Both treatments were safe for the babies with comparable Apgar scores. This study suggests that Norepinephrine infusion at 0.05 mcg/kg/min is more effective than phenylephrine at 0.25 mcg/kg/min in preventing hypotension during low-dose SA in CD, providing better hemodynamic stability and fewer episodes of bradycardia
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07327320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07327320 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tam Anh Research Institute
- Last refreshed: 21 January 2026
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing