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.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
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

e083202

Informations 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.

Auteurs

Wenhui Tao (W)

Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, Anhui Medical University, Hefei, China.

Yufang Xie (Y)

Department of Anesthesiology, The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, Hefei, China.

Jinfeng Bao (J)

Department of Anesthesiology, The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, Hefei, China.

Wei Ding (W)

Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, Anhui Medical University, Hefei, China.

Ye Zhang (Y)

Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, China huxianwen001@163.com zhangye_hassan@sina.com.
Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, Anhui Medical University, Hefei, China.

Xianwen Hu (X)

Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Anhui Medical University, Hefei, China huxianwen001@163.com zhangye_hassan@sina.com.
Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, Anhui Medical University, Hefei, China.

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Classifications MeSH