Comparison of the effects of norepinephrine and phenylephrine on shivering and hypothermia in patients undergoing caesarean section under spinal anaesthesia at a tertiary hospital in China:a randomised, double-blind, controlled trial protocol.
Humans
Anesthesia, Spinal
/ methods
Shivering
/ drug effects
Cesarean Section
/ adverse effects
Female
Double-Blind Method
Pregnancy
Norepinephrine
/ therapeutic use
China
/ epidemiology
Tertiary Care Centers
Hypothermia
/ prevention & control
Phenylephrine
/ therapeutic use
Adult
Anesthesia, Obstetrical
/ methods
Vasoconstrictor Agents
/ therapeutic use
Randomized Controlled Trials as Topic
anaesthesia in obstetrics
clinical trial
maternal medicine
protocols & guidelines
vascular medicine
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
11 Jul 2024
11 Jul 2024
Historique:
medline:
12
7
2024
pubmed:
12
7
2024
entrez:
11
7
2024
Statut:
epublish
Résumé
Peripheral vasodilation causes a redistribution of body temperature from the core to the periphery, resulting in shivering and hypothermia. These are normal pathological and physiological processes during spinal anaesthesia. Two drugs, norepinephrine and phenylephrine, have peripheral vasoconstrictive effects. It is unclear the effects of norepinephrine and phenylephrine on shivering and hypothermia in patients undergoing caesarean section under spinal anaesthesia. 240 eligible parturients will be recruited for this randomised, double-blind, controlled trial and randomly assigned to either the norepinephrine or phenylephrine groups. The primary outcome will be the incidence of shivering while secondary outcomes will include the severity of shivering, rectal temperature, incidence of hypothermia and umbilical artery blood pH value. The Institutional Ethics Committee of The Second People's Hospital of Hefei approved the trial protocol (ID: 2023-093). The results will be published in a compliant journal. The original data will be released in December 2029 on the ResMan original data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn). ChiCTR2300077164.
Identifiants
pubmed: 38991676
pii: bmjopen-2023-083202
doi: 10.1136/bmjopen-2023-083202
doi:
Substances chimiques
Norepinephrine
X4W3ENH1CV
Phenylephrine
1WS297W6MV
Vasoconstrictor Agents
0
Types de publication
Journal Article
Clinical Trial Protocol
Randomized Controlled Trial
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e083202Informations de copyright
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.