Preoperative Oral Carbohydrate on Gastric Emptying

NCT06289543 | Recruiting

• 1 other identifier: BVU-ESTELOGLU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa.

Conditions

Vomit Aspiration; Anxiety

Outcome Measures

Primary Outcomes (1)

• Gastric volume

  Assessment of gastric volume by ultrasound

  prior to anesthesia induction

Secondary Outcomes (5)

• preoperative anxiety

  before coming to the operating room, Scored between 20 and 80 points. A high score indicates high anxiety

• postoperative nausea and vomiting

  up to postoperative 24 hours, numeric rank score is scored between 0 and 3 points

• thirst, hunger, fatigue, dry mouth

  before drink (2 hous before surgery), prior to anesthesia induction, visual analog scale is scored between 0 and 10

• Postoperative Pain Score

  up to postoperative 24 hours, visual analog scale is scored between 0 and 10

• postoperative insulin resistance

  glucose, insulin and cortisol will be measured 2 hours before surgery(before drink), before induction and 2 hours postoperatively

Study Arms (3)

Starvation

NO INTERVENTION

Fasting for 6-8 hours before the operation

Water

ACTIVE COMPARATOR

drink 400ml of water 2 hours before the operation

Dietary Supplement: Preoperative carbohydrate solution

oral carbohydrate

ACTIVE COMPARATOR

drink 400ml of solution 2 hours before the operation

Dietary Supplement: Preoperative carbohydrate solution

Interventions

Preoperative carbohydrate solution DIETARY_SUPPLEMENT

water and solution will be given to patients to drink 2 hours before the operation

Also known as: Water

Water; oral carbohydrate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65
• Elective laparoscopic cholecystectomy planned under general anesthesia
• American Society of Anesthesiologists (ASA) class I-II physical condition

You may not qualify if:

• Patients with gastroesophageal reflux and gastrointestinal motility disorders diabetes mellitus Mental retardation, previous neurological disease symptoms (syncope, dementia, Alzheimer, etc.) Chronic alcoholism Difficult Intubation Patients with ASA physical status classes ≥III Patients with a body mass index of 35 and above History of Meniere and motion sickness Presence of previous history of postoperative nausea and vomiting Smoking

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem University

Istanbul, Fatih, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Water

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Emine Seyda Teloglu

CONTACT

+905394191544; eteloglu@bezmialem.edu.tr

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: Physician, Department of Anesthesiology

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: March 4, 2024
• Study Start: January 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 15, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)