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Study of the impact of preoperative oral rehydration on the incidence of spinal anesthesia-induced hypotension for scheduled cesarean section.
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 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting | No Intervention | Patient will be "nil per os" from midnight before their cesarean section | |
| Rehydration | Active Comparator | Patient will receive 400 mL of Nutricia Preop ® 2 hours before their cesarean section |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutricia PreOp | Dietary Supplement | Oral rehydration 2 hours before the scheduled cesarean section under spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension reduction | We aim for a 50% reduction in the incidence of hypotension following spinal anesthesia for scheduled C-section. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| N+/V+ | Incidence of nausea and/or vomiting | 60 minutes |
| Umbilical pH | Umbilical pH | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' satisfaction | Patients' satisfaction measured by a questionary | 24 hours |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denis Schmartz, MD | Contact | 3224773996 | denis.schmartz@chu-brugmann.be | |
| Philippe Van Der Linden, MD | Contact | 3224773996 | philippe.vanderlinden@chu-brugmann.be |
| Name | Affiliation | Role |
|---|---|---|
| Denis Schmartz, MD | CHU Brugmann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brugmann | Recruiting | Brussels | 1020 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23720079 | Background | Havas F, Orhan Sungur M, Yenigun Y, Karadeniz M, Kilic M, Ozkan 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. | |
| 21307770 | Background | 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. No abstract available. |
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| 30351587 | Background | 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. |
| 23200124 | Background | 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. |
| 19859776 | Background | 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. |
| 25581289 | Background | Kim J, Adhikari M, Dhamane S, Hagstrom 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. |