Effects of Taking Fluids before Surgery in gynecological patients

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-66gqfs
• Date of registration: 18/04/2018
• Prospective Registration: No
• Primary sponsor: Universidade Federal de São Paulo
• Public title: Effects of Taking Fluids before Surgery in gynecological patients
• Scientific title: Effects of Preoperative Fasting in gynecological patients - : PREOPERATIVE FASTING ABBREVIATION
• Date of first enrolment: 03/01/2016
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-66gqfs
• Study type: Intervention
• Study design: Clinical trial of prevention, parallel, with two arms, controlled-randomized, double-blind.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Gisele Vissoci Marquini
• Affiliation: Universidade Federal de São Paulo

• Name: Gisele Vissoci Marquini
• Affiliation: Universidade Federal de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: women; age between 18 and 70; body mass index less than 40 kg/m2; have a pre-anesthetic evaluation with a classification without surgical risk taking into consideration the classification of the American Association of Anesthesiology.
Exclusion criteria: patients with gastrointestinal, respiratory, C-reactive protein levels greater than 6mg/dL; time of surgery greater than 4 hours, use of steroids for more than 6 months before surgery.

Age minimum: 18Y
Age maximum: 70Y
Gender: F

Health Condition(s) or Problem(s) studied

G02.111.158

Carbohydrate metabolism. Insulin resistance.

C18.452.394.968.500

Intervention(s)

Dietary supplement

Patients with gynecological surgery scheduled for a period of 6 months (approximately 30 in each group) will be invited to participate in the research, after pre-anesthetic release for the procedure, with project clarification meetings and application of the exclusion criteria.
Exclusion criteria are: infections, gastroesophageal reflux, morbid obesity, use of corticosteroids for up to 6 months prior to surgery, renal or hepatic disease, C-reactive protein> 6 mg / dl, diabetes mellitus and estimated time of surgery exceeding 4 hours.
After excluding the patients in special situations, or with contraindication to the abbreviation of the preoperative fast, those who meet the eligibility criteria and who agree to participate in the research, signed the Informed Consent Term (TCLE).
The patients will be randomized by the researcher through the program EXCEL 2014, in two groups, who will receive, through one of the coauthors, the following detailed solutions:
Control Group: Inert solution containing distilled water, 4 drops of red dye and 2 drops of sucrose based sweetener.
Juice or Experimental Group: Clarified supplement rich in carbohydrate (89%) and whey protein (11%), free from fats and fibers.
Following the randomization of the groups, the delivery of the liquid to be ingested, with guidelines, in writing, about the time of ingestion of the contents, hospitalization time and fasting for solid 12 hours before surgery, will be offered, following the preanesthetic recommendation of the service. Patients included in the study will be instructed to ingest their sample four hours prior to surgery.
We chose four hours instead of two hours as permitted in the literature, in order to respect the paradigm shift in a gradual manner, which would possibly pre

SP6.051.227

Primary Outcome(s)

Presentation of the Outcome found- the coefficient of variation of the median difference in blood glucose (55.19%), insulin (30.73%), albumin (2.33%) and HOMA (17.27%), between pre- and postoperative (32.53%), insulin (22.3%), albumin (0.91%), and HOMA (8%) were significantly higher in the control groups than in the control groups. , 46%) between the pre and postoperative phases of the juice group.
There was a more than half decrease in insulin resistance in the group with carbohydrate and protein solution ingestion compared to the control in the pre and post-intervention measurements.

Presentation of the expected outcome- the abbreviation of preoperative fasting with carbohydrate-enriched liquid and protein may decrease insulin resistance; (HOMA index), with a decrease of at least 5% of that index in the group with carbohydrate and protein solution ingestion compared to the control group in the pre and post-intervention measurements.

Secondary Outcome(s)

Secondary outcomes are not expected

Source(s) of Monetary Support

Universidade Federal de São Paulo

Secondary Sponsor(s)

Universidade Federal de São Paulo