Post Spinal Anesthesia Hypotension and Preoperative Hydration

Cesarean Section Clinical Trial

Official title:

Impact of Preoperative Oral Rehydration on the Incidence of Spinal Anesthesia-induced Hypotension for Scheduled Cesarean Section.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04450667
• Other study ID #: CHUB_MATHYPOTA
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2021
• Source: Brugmann University Hospital
• Contact: Denis Schmartz, MD
• Phone: 3224773996
• Email: denis.schmartz[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of the impact of preoperative oral rehydration on the incidence of spinal anesthesia-induced hypotension for scheduled cesarean section.

Description:

What is already known ? Arterial hypotension is one of the most common complications following spinal anesthesia (60%). Several measures have been studied to prevent this hypotension, such as intravenous vascular filling (preloading, coloading), using different filling fluids (colloids vs crystalloids), preventive administration of vasopressors, reduction of doses and volumes administered in spinal anesthesia.

Only one study has evaluated the impact of oral rehydration on hypotension after spinal anesthesia.

Hypothesis:

The investigatord wish to demonstrate that an oral rehydration 2 hours before surgery, reduces by 50% the incidence of hypotension and / or the use of vasopressors, after spinal anesthesia

Primary outcome:

Decrease in the incidence of hypotension and / or use of vasopressor agents by 50% in the "rehydration" group compared to the "fasting" group.

Secondary outcomes:

Reduced incidence of nausea / vomiting side effects, effect on umbilical pH, APGAR score, patient satisfaction

Design:

Interventional clinical study. Monocentric, single-blind, randomized, single-blind, controlled trial with 2 groups of 50 patients.

Inclusion criteria:

Patients ≥ 18 years old Scheduled for a scheduled cesarean, under spinal anesthesia Signature of informed consent Single pregnancy of ≥ 36 weeks 150 cm

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years old

• Scheduled for a scheduled cesarean, under spinal anesthesia (CSE)

• Signature of informed consent

• Single pregnancy of = 36 weeks

• 150 cm <height <180 cm

• 50 kg <weight <100 kg

Exclusion Criteria:

• Patient's refusal

• Contraindication to spinal anesthesia

• Allergy to a product used for anesthesia

• Age < 18

• Known or pregnancy-related hypertension

• Gestational diabetes with insulin or pre-existing diabetes with insulin

• Total language barrier without possibility of translation

• ASA = 3

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Cesarean Section
• Hypotension

Intervention

Dietary Supplement:
• Nutricia PreOp
Oral rehydration 2 hours before the scheduled cesarean section under spinal anesthesia

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. — View Citation

Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7. — View Citation

Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27. — View Citation

Havas F, Orhan Sungur M, Yenigün Y, Karadeniz M, Kiliç M, Özkan Seyhan T. Spinal anesthesia for elective cesarean section is associated with shorter hospital stay compared to general anesthesia. Agri. 2013;25(2):55-63. doi: 10.5505/agri.2013.42204. — View Citation

Itoh S, Arai M, Kuroiwa M, Ando H, Okamoto H. [Effect of Preoperative Oral Rehydration on the Hypotension during Spinal Anesthesia.]. Masui. 2016 Sep;65(8):786-789. Japanese. — View Citation

Kim J, Adhikari M, Dhamane S, Hagström AE, Kourentzi K, Strych U, Willson RC, Conrad JC. Detection of viruses by counting single fluorescent genetically biotinylated reporter immunophage using a lateral flow assay. ACS Appl Mater Interfaces. 2015 Feb 4;7(4):2891-8. doi: 10.1021/am5082556. Epub 2015 Jan 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' satisfaction	Patients' satisfaction measured by a questionary	24 hours
Primary	Hypotension reduction	We aim for a 50% reduction in the incidence of hypotension following spinal anesthesia for scheduled C-section.	60 minutes
Secondary	N+/V+	Incidence of nausea and/or vomiting	60 minutes
Secondary	Umbilical pH	Umbilical pH	60 minutes