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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06243367
Other study ID # 35129/12/21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date April 1, 2024

Study information

Verified date February 2024
Source Tanta University
Contact Eman M AboOmar, Master
Phone 00201090822808
Email emantaher6669@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.


Description:

The surgical patients are influenced by many stressors during operation such as the prolonged fasting hours. Importantly, these stressors are iatrogenic and have been shown to disturb homeostasis with little benefit. Surgery itself, induces an endocrine and inflammatory stress response and contributes to postoperative insulin resistance (PIR) which increased also by Preoperative fasting. Postoperative insulin resistance is a state of reduced insulin-mediated glucose uptake in skeletal muscles and adipose tissue, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia. Strategies to reduce the postoperative stress response and postoperative insulin resistance include shortening the preoperative fasting time via preoperative carbohydrate oral drink administration (carbohydrate load). Preoperative fasting is the first step in postoperative insulin resistance development. The traditional fasting time of 6-8 h before elective surgery to prevent pulmonary aspiration usually extends up to 12 h in anesthetic practice. Overnight fasting is a physiological state of reduced insulin sensitivity due to the normal hormonal diurnal rhythm. If patients undergo surgery in the prolonged fasted state, insulin resistance may begin even before surgery. A preoperative carbohydrate drink acts as a morning meal, may improve insulin sensitivity and propel the patient's metabolic state towards anabolism. The rationale of this study is to compare the differences between preoperative CHO loading and a conventional fasting protocol on the postoperative insulin resistance, Glasgow prognostic score (GPS), subjective patient well-being and surgical clinical outcome.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria: - Age from 21 and 70 years. - Both sexes. - American Society of Anesthesiologists (ASA) physical status l & ll. - Scheduled for elective major abdominal surgery Exclusion Criteria: - Disseminated malignant disease. - Increased risk for gastric content aspiration. - Body Mass Index (BMI) below 20 or above 30 kg/m2. - Nutritional risk screening 2002 score above 3. - Emergency surgery, diabetic patients, immunomodulatory therapy. - Refusal of the patient.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Placebo drink
Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery
Dietary Supplement:
Carbohydrate
Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved.

Locations

Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The metabolic response The patient was also subjected to further assessment by bioelectrical impedence analysis for measuring of the basal body muscle mass preoperatively and 5 days postoperatively. 5 days postoperatively
Secondary The postoperative inflammatory response Postoperative inflammatory response was assessed at 6 o'clock A.M on the day of surgery (T1, basal value), 6 h after surgery (T2), at 6 o'clock A.M on postoperative day 1 (T3) . First day postoperative
Secondary Complications Complications such as nausea and vomiting were assessed preoperatively and at intervals 4, 8, 12, and 24 hours postoperatively 24 hours postoperatively
Secondary Time of independent ambulation Time of independent ambulation will be recorded. 27 days postoperatively
Secondary Postoperative discharge day Postoperative discharge day will be recorded. 27 days postoperatively
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