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Reduction of preoperative fasting time on scheduled cesarean section

Abreviation of the fasting pre-operative in the cesarean elective - ACEleration of Post-operative TOtal Recovery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7bn9gc
Enrollment
Unknown
Registered
2019-10-02
Start date
2019-09-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women

Interventions

The prospective, randomized, controlled trial was performed with pregnant women candidates for elective cesarean section at the Santa Helena-Cuiabá Hospital outpatient surgical unit (Presidente Marque
Control group (G2): the 11 patients will remain without ingesting solid and liquid foods for 8 hours before induction of anesthesia and will not receive any type of drink or food
Placebo Group (G3): The 11 patients will remain without ingesting solid foods for 6 hours prior to anesthetic induction, but will drink pure water six and 2 hours prior to anesthetic induction. Nutrit
Dietary supplement

Sponsors

Hospital Universitário Julio Müller HUJM
Lead Sponsor
Universidade Federal de Mato Grosso UFMT
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women 18 to 40 years of age; above 39 gestational weeks Present body mass index (BMI kg / m²) suitable for gestational age according to the chart of Atalah et al 1997 Single fetus Elective caesarean with wall opening abdominal pain by the Pfannenstiel technique Present ASA (American Society of Anesthesiologist) score I and II Be submitted to the regional anesthetic technique; Ability to understand the rationale of the study evaluations; Signed the free and informed consent form.

Exclusion criteria

Exclusion criteria: Patients who do not adhere to the protocol at any stage of the study and who present: Anemia (Hb 140/90 mmHg); Renal or hepatic disease; C-reactive protein> 6.0 mg / L; Clinical repercussion of gastroesophageal reflux for the gravidic condition (Hyperemesis gravidarum, abnormal anatomy of the upper gastrointestinal tract); Operating time greater than two hours; Blood collection in the non-scheduled period; Preoperative complications requiring an emergency or major intraoperative cesarean section (eg hemorrhage).

Design outcomes

Primary

MeasureTime frame
To attenuate the organic response to elective cesarean section with the ingestion of a liquid formula containing carbohydrate and glutamine; ;Decrease the inflammatory markers PCR and I-6 with variation of at least 5% between the experimental and control groups;;Decrease HOMA-IR (homeostasis model assessment-insulin resistance: glycemia x insulin / 405) with variation of at least 5% between the experimental and control groups;;Maintain the palmar grip strength, measured by the manual dynamometer, noting a difference of at least 5% between the experimental and control groups.

Secondary

MeasureTime frame
Reduce hunger (self-reported response);Reduce thirst (self-reported response);Avoid hypoglycemia (measured by biochemical blood glucose values) with a difference of at least 5% between groups.

Countries

Brazil

Contacts

Public ContactAmílcar ;Cervantes Damazo;Caporossi

Universidade Federal de Mato Grosso UFMT;Universidade Federal de Mato Grosso UFMT

coordenacao.ppgcs@gmail.com;caporosi@terra.com.br+55-014-6536156221;+55-014-65999818781

Outcome results

None listed

Source: REBEC (via WHO ICTRP)