NCT02542748

Brief Summary

Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

October 5, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

September 3, 2015

Last Update Submit

January 12, 2019

Conditions

HypotensionObstetrical Complication of AnesthesiaComplications; Cesarean Section

Keywords

norepinephrineephedrine

Outcome Measures

Primary Outcomes (1)

  • incidence of hypotension

    from immediately after spinal anesthesia to 30min after spinal anesthesia

Secondary Outcomes (13)

  • pH value of fetal arterial blood

    just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  • incidence of nausea and vomiting

    from immediately after spinal anesthesia to 30min after spinal anesthesia

  • incidence of dizzy

    from immediately after spinal anesthesia to 30min after spinal anesthesia

  • incidence of chest congestion

    from immediately after spinal anesthesia to 30min after spinal anesthesia

  • fetal arterial partial pressure of oxygen

    just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  • +8 more secondary outcomes

Study Arms (2)

norepinephrine

EXPERIMENTAL

norepinephrine is injected after spinal anesthesia

Drug: Norepinephrine

ephedrine

OTHER

ephedrine is injected after spinal anesthesia

Drug: Ephedrine

Interventions

NorepinephrineDRUG

norepinephrine injection

Also known as: vasoactive agents
norepinephrine
EphedrineDRUG

Ephedrine injection

Also known as: vasoactive agents
ephedrine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective cesarean section

You may not qualify if:

  • Patients with severe pre-eclampsia
  • Patients with contraindications for spinal anesthesia
  • Patients with multiple pregnancy
  • Patients with gestation \<38w

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital,Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (4)

  • Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.

    PMID: 25654435BACKGROUND

  • Moslemi F, Rasooli S. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial. Iran J Med Sci. 2015 Jan;40(1):19-26.

    PMID: 25649721BACKGROUND

  • Mitra JK, Roy J, Bhattacharyya P, Yunus M, Lyngdoh NM. Changing trends in the management of hypotension following spinal anesthesia in cesarean section. J Postgrad Med. 2013 Apr-Jun;59(2):121-6. doi: 10.4103/0022-3859.113840.

    PMID: 23793313BACKGROUND

  • Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, Jiang XF, Wu ZX, Xiong LZ, Lu ZH. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021 Mar 4;134(7):792-799. doi: 10.1097/CM9.0000000000001404.

    PMID: 33661141DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

NorepinephrineEphedrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPropanolaminesPropanolsPhenethylaminesEthylamines

Study Officials

  • Hailong DONG, Prof.

    Xijing Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

October 5, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

CN(1)