The Influence of Leg Elevation on Noradrenaline Requirements During Cesarean Delivery

NCT ID: NCT06822699

Last Updated: 2025-05-13

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-14

Study Completion Date

2025-05-08

Brief Summary

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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

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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

Conditions

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Spinal Hypotension Hypoperfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Leg elevation group

leg will be elevated 30 degrees immediately after spinal anesthesia

Group Type EXPERIMENTAL

Leg elevation

Intervention Type DEVICE

leg will be raised 30 degrees after spinal anesthesia using standardized pillow

Control group

Legs will remain supine after spinal anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Leg elevation

leg will be raised 30 degrees after spinal anesthesia using standardized pillow

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mina Adolf Helmy

lecture of anesthesia and critical care Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 28438121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39047530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30335625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29090733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34034957 (View on PubMed)

Helmy MA, Naguib NN, Helmy KA, Milad LM. 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. J Anesth Analg Crit Care. 2025 Oct 28;5(1):73. doi: 10.1186/s44158-025-00290-7.

Reference Type DERIVED
PMID: 41152963 (View on PubMed)

Other Identifiers

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leg elevation and noradrenalin

Identifier Type: -

Identifier Source: org_study_id

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