Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients

NCT ID: NCT02542748

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-05

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. Ephedrine could be used to treat hypotension but lead to lower fetal pH, which may be related to worse fetal outcome.Norepinephrine could improve the hypotension to the same extent as phenylephrine. In this study, we tend to compare the effects of norepinephrine and ephedrine on hypotension in parturients and on fetal acid status.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension Obstetrical Complication of Anesthesia Complications; Cesarean Section

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

norepinephrine

norepinephrine is injected after spinal anesthesia

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

norepinephrine injection

ephedrine

ephedrine is injected after spinal anesthesia

Group Type OTHER

Ephedrine

Intervention Type DRUG

Ephedrine injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Norepinephrine

norepinephrine injection

Intervention Type DRUG

Ephedrine

Ephedrine injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

vasoactive agents vasoactive agents

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients scheduled for elective cesarean section

Exclusion Criteria

* Patients with severe pre-eclampsia
* Patients with contraindications for spinal anesthesia
* Patients with multiple pregnancy
* Patients with gestation \<38w
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhihong LU

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hailong DONG, Prof.

Role: STUDY_CHAIR

Xijing Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital,Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25654435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25649721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23793313 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33661141 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJH-A-2015-5-5-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ephedrine and Phenylephrine for Spinal Hypotension
NCT03047109 COMPLETED PHASE2/PHASE3