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

Overview

Journal BMJ Open

Specialty General Medicine

Date 2024 Jul 11

PMID 38991676

Authors

Wenhui Tao

Yufang Xie

Jinfeng Bao

Wei Ding

Ye Zhang

Xianwen Hu

Affiliations

Soon will be listed here.

Abstract

Introduction: 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.

Methods Analysis: 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.

Ethics And Dissemination: 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).

Trial Registration Number: ChiCTR2300077164.

References

Rangasamy V, de Guerre L, Xu X, Schermerhorn M, Novack V, Subramaniam B . Association Between Intraoperative Hypotension and Postoperative Adverse Outcomes in Patients Undergoing Vascular Surgery - A Retrospective Observational Study. J Cardiothorac Vasc Anesth. 2020; 35(5):1431-1438. DOI: 10.1053/j.jvca.2020.11.005. View

Feng G, Wang Y, Feng J, Luo X, Li C, Yao S . The relationship between core temperature and perioperative shivering during caesarean section under intrathecal anesthesia with bupivacaine and ropivacaine: a randomized controlled study. J Anesth. 2021; 35(6):889-895. PMC: 8595161. DOI: 10.1007/s00540-021-02995-9. View

Theodoraki K, Hadzilia S, Valsamidis D, Stamatakis E . Prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. Α double-blinded randomized controlled trial. Int J Surg. 2020; 84:41-49. DOI: 10.1016/j.ijsu.2020.10.006. View

Lopez M . Postanaesthetic shivering - from pathophysiology to prevention. Rom J Anaesth Intensive Care. 2018; 25(1):73-81. PMC: 5931188. DOI: 10.21454/rjaic.7518.251.xum. View

Mohta M, Dubey M, Malhotra R, Tyagi A . Comparison of the potency of phenylephrine and norepinephrine bolus doses used to treat post-spinal hypotension during elective caesarean section. Int J Obstet Anesth. 2019; 38:25-31. DOI: 10.1016/j.ijoa.2018.12.002. View

Hilton E, Wilson S, Wolf B, Hand W, Roberts L, Hebbar L . Effect of Intraoperative Phenylephrine Infusion on Redistribution Hypothermia During Cesarean Delivery Under Spinal Anesthesia. J Clin Anesth Manag. 2020; 1(1). PMC: 7272055. DOI: 10.16966/2470-9956.103. View

Law A, Bosch N, Peterson D, Walkey A . Comparison of Heart Rate After Phenylephrine vs Norepinephrine Initiation in Patients With Septic Shock and Atrial Fibrillation. Chest. 2022; 162(4):796-803. PMC: 9808602. DOI: 10.1016/j.chest.2022.04.147. View

Alipour M, Taghavi Gillani M, Bameshki A, Razavi M, Mashhadi L, Amiriani M . Evaluation of Amino Acid Infusion preventive effect on Hypothermia during Spinal Anesthesia for Hip Arthroplasty. Arch Bone Jt Surg. 2022; 10(7):627-632. PMC: 9382258. DOI: 10.22038/ABJS.2022.54665.2724. View

Sheng Z, Shen Y, Pan Z, Zhu M, Sun H, Liu J . Comparative study on the manually-controlled variable-rate versus fixed-rate infusion of norepinephrine for preventing hypotension during spinal anesthesia for cesarean delivery. J Clin Anesth. 2022; 82:110944. DOI: 10.1016/j.jclinane.2022.110944. View

10.

Wan J, Li X, Zeng S, Li Y, Wang F . Comparison of intravenous butorphanol vs. tramadol for post-spinal anesthesia shivering: a meta-analysis and systematic review. Front Med (Lausanne). 2023; 10:1271664. PMC: 10729005. DOI: 10.3389/fmed.2023.1271664. View

11.

Uerpairojkit K, Thongthaweeporn N, Anusorntanawat R, Pipanmekaporn T, Hinthong T, Bunchungmongkol N . A randomized comparison of hemodynamic changes in response to a heart rate-dependent phenylephrine/ephedrine protocol versus ephedrine-only for spinal hypotension during elective cesarean section. J Obstet Gynaecol Res. 2022; 48(7):1750-1759. DOI: 10.1111/jog.15289. View

12.

Guo L, Xu X, Qin R, Shi Y, Xue W, He L . Prophylactic Norepinephrine and Phenylephrine Boluses to Prevent Postspinal Anesthesia Hypotension During Cesarean Section: A Randomized Sequential Allocation Dose-Finding Study. Drug Des Devel Ther. 2023; 17:1547-1555. PMC: 10224683. DOI: 10.2147/DDDT.S406671. View

13.

Mohammadzadeh Jouryabi A, Sharami S, Ghanaie M, Sedighinejad A, Imantalab V, Rafiee Sorouri Z . Comparing the Effects of Low Dose of Ketamine, Tramadol, and Ondansetron in Prevention of Post Spinal Anesthesia Shivering in Cesarean Section. Anesth Pain Med. 2021; 11(4):e116429. PMC: 8520676. DOI: 10.5812/aapm.116429. View

14.

Guo L, Qin R, Ren X, Han C, Xue W, He L . Prophylactic norepinephrine or phenylephrine infusion for bradycardia and post-spinal anaesthesia hypotension in patients with preeclampsia during Caesarean delivery: a randomised controlled trial. Br J Anaesth. 2022; 128(5):e305-e307. DOI: 10.1016/j.bja.2022.01.027. View

15.

Wang X, Mao M, Zhang S, Wang Z, Xu S, Shen X . Bolus norepinephrine and phenylephrine for maternal hypotension during elective cesarean section with spinal anesthesia: a randomized, double-blinded study. Chin Med J (Engl). 2020; 133(5):509-516. PMC: 7065858. DOI: 10.1097/CM9.0000000000000621. View

16.

Mohta M, R L, Chilkoti G, Agarwal R, Malhotra R . A randomised double-blind comparison of phenylephrine and norepinephrine for the management of postspinal hypotension in pre-eclamptic patients undergoing caesarean section. Eur J Anaesthesiol. 2021; 38(10):1077-1084. DOI: 10.1097/EJA.0000000000001461. View

17.

Safavi M, Honarmand A, Rahmanikhah E, Badiei S, Attari M . Intrathecal Meperidine versus intrathecal Fentanyl for prevention of shivering in lower limb orthopedic surgeries under spinal anesthesia: A randomized double-blind placebo-controlled trial. J Res Pharm Pract. 2014; 3(4):137-41. PMC: 4262860. DOI: 10.4103/2279-042X.145390. View

18.

Chen Y, Xu X, Qin R, Guo L, Ni X . Comparison of crystalloid and colloid co-load combined with norepinephrine prophylaxis on post-spinal anesthesia hypotension during cesarean delivery: a randomized sequential allocation dose-finding study. Front Med (Lausanne). 2023; 10:1214598. PMC: 10505435. DOI: 10.3389/fmed.2023.1214598. View

19.

Chan A, Tetzlaff J, Gotzsche P, Altman D, Mann H, Berlin J . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 346:e7586. PMC: 3541470. DOI: 10.1136/bmj.e7586. View

20.

Liu P, He H, Zhang S, Liang Y, Gao Z, Yuan H . Comparative efficacy and safety of prophylactic norepinephrine and phenylephrine in spinal anesthesia for cesarean section: A systematic review and meta-analysis with trial sequential analysis. Front Pharmacol. 2022; 13:1015325. PMC: 9742368. DOI: 10.3389/fphar.2022.1015325. View