NCT06822699

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2025

Completed
Last Updated

May 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 7, 2025

Last Update Submit

May 8, 2025

Conditions

Spinal HypotensionHypoperfusion

Outcome Measures

Primary Outcomes (1)

  • Average noradrenaline requirements

    average noradrenaline requirements in both groups (mcg/kg/min)

    baseline to delivery of the baby

Secondary Outcomes (3)

  • Total noradrenaline requirements

    baseline to delivery

  • incidence of spinal hypotension

    baseline to delivery

  • incidence of severe hypotension

    baseline to delivery

Study Arms (2)

Leg elevation group

EXPERIMENTAL

leg will be elevated 30 degrees immediately after spinal anesthesia

Device: Leg elevation

Control group

NO INTERVENTION

Legs will remain supine after spinal anesthesia

Interventions

Leg elevationDEVICE

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

Leg elevation group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women undergoing elective ceserean section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • full term
  • singleton pregnancy
  • ASA II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 6890, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 28438121BACKGROUND

  • 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.

    PMID: 39047530BACKGROUND

  • 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.

    PMID: 30335625BACKGROUND

  • 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.

    PMID: 29090733BACKGROUND

  • 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.

    PMID: 34034957BACKGROUND

  • 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.

    PMID: 41152963DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of anesthesia and critical care Cairo University

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 12, 2025

Study Start

March 14, 2025

Primary Completion

May 8, 2025

Study Completion

May 8, 2025

Last Updated

May 13, 2025

Record last verified: 2025-03

Locations

EG(1)