Clinical trial NCT06822699: The Influence of Leg Elevation on Noradrenaline Requirements During Cesarean Delivery
Official title: The Influence of Thirty-degree Leg Elevation on Noradrenaline Requirements Administered as a Prophylactic Variable Infusion During Cesarean Delivery: An Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Hypotension
Hypoperfusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Spinal anesthesia is a widely chosen technique in obstetric theaters due to several advantages, however sympathetic block results in hypotension that carry several consequences on maternal and fetal health, thus early prediction and management takes high priority. in this regards recent recommendations suggest the use of prophylactic vasopressors like noradrenaline, researchers of this study aimed to explore the impact of leg elevation on prophylactic noradrenaline dose

Detailed description: after spinal anesthesia, patients will be randomly allocated into 2 groups : Leg elevation group and control group.

noradrenaline will be used as variable infusion starting from 0.05 microgram/kg/min up to 0.14 microgram /kg/minute.

noradrenaline infusion will be continued till delivery of the baby

Eligibility criteria: Inclusion Criteria:

* full term
* singleton pregnancy
* ASA II

Exclusion Criteria:

* decline to participate
* baseline SBP \<100 mmHg
* failed spinal anesthesia
* allergy to local anesthetic
* coagulopathy

Primary outcomes:
measure: Average noradrenaline requirements
timeFrame: baseline to delivery of the baby
Secondary outcomes:
measure: Total noradrenaline requirements
timeFrame: baseline to delivery
measure: incidence of spinal hypotension
timeFrame: baseline to delivery
measure: incidence of severe hypotension
timeFrame: baseline to delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza Governorate
Study officials:
References:
citation: Hasanin A, Aiyad A, Elsakka A, Kamel A, Fouad R, Osman M, Mokhtar A, Refaat S, Hassabelnaby Y. Leg elevation decreases the incidence of post-spinal hypotension in cesarean section: a randomized controlled trial. BMC Anesthesiol. 2017 Apr 24;17(1):60. doi: 10.1186/s12871-017-0349-8.
citation: Lyu W, Zhang Z, Li C, Wei P, Feng H, Zhou H, Zheng Q, Zhou J, Li J. Intravenous initial bolus during prophylactic norepinephrine infusion to prevent spinal hypotension for cesarean delivery: A randomized controlled, dose-finding trial. J Clin Anesth. 2024 Oct;97:111562. doi: 10.1016/j.jclinane.2024.111562. Epub 2024 Jul 23.
citation: Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.
citation: Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
citation: Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.