NCT04450667

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

June 24, 2020

Last Update Submit

November 4, 2021

Conditions

Anesthesia, SpinalCesarean Section

Outcome Measures

Primary Outcomes (1)

  • Hypotension reduction

    We aim for a 50% reduction in the incidence of hypotension following spinal anesthesia for scheduled C-section.

    60 minutes

Secondary Outcomes (2)

  • N+/V+

    60 minutes

  • Umbilical pH

    60 minutes

Other Outcomes (1)

  • Patients' satisfaction

    24 hours

Study Arms (2)

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

Dietary Supplement: Nutricia PreOp

Interventions

Nutricia PreOpDIETARY_SUPPLEMENT

Oral rehydration 2 hours before the scheduled cesarean section under spinal anesthesia

Rehydration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years old
  • Scheduled for a scheduled cesarean, under spinal anesthesia (CSE)
  • Signature of informed consent
  • Single pregnancy of ≥ 36 weeks
  • cm \<height \<180 cm
  • kg \<weight \<100 kg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23720079BACKGROUND

  • 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.

    PMID: 21307770BACKGROUND

  • 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.

    PMID: 30351587BACKGROUND

  • 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.

    PMID: 23200124BACKGROUND

  • 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.

    PMID: 19859776BACKGROUND

  • 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.

    PMID: 25581289BACKGROUND

Study Officials

  • Denis Schmartz, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis Schmartz, MD

CONTACT

3224773996denis.schmartz@chu-brugmann.be

Philippe Van Der Linden, MD

CONTACT

3224773996philippe.vanderlinden@chu-brugmann.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department, anesthesiology

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

January 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)