The Effect of Oral Carbohydrate Inhalation Given to Patients Before Coronary Artery Bypass Graft Operation on Recovery

January 23, 2025 updated by: Yasemin Bozkurt

Investigation of the Effects of Oral Carbohydrate Solution Given to Patients Before Coronary Artery Bypass Graft Surgery on Postoperative Nausea and Vomiting, Feeling of Hunger and Thirst, Physiological Parameters and Recovery

The aim of this study was to investigate the effect of oral carbohydrate solution given to patients before coronary artery bypass graft surgery on nausea-vomiting, hunger, thirst, physiologic parameters and recovery.

The study will be completed with a total of 120 participants, 40 control, 40 placebo and 40 experimental.

As a randomization method, simple randomization method will be used to provide an equal number of samples in three groups and patients will be informed verbally about the study and written informed consent will be obtained from patients who agree.

In this study, the effects of oral carbohydrate solution administration on nausea and vomiting, hunger, thirst, physiologic parameters and recovery were evaluated before coronary artery bypass graft surgery.

Study Overview

Detailed Description

Experimental: Oral administration of carbohydrate solution Patients will receive 800 ml of oral carbohydrate solution until midnight before surgery and 400 ml until 2 hours before surgery. Patients will be administered a Patient Information Form before surgery. Postoperative Recovery Index (Turkish Version), Visual Comparison Scale, Physiologic Parameters and Blood Glucose Monitoring Form and Number and Dosage of Antiemetic Drugs Taken in 24 Hours Postoperatively will be applied.

Placebo: Administration of flavored water Patients will be given 800 ml of flavored water until midnight before surgery and 400 ml of flavored water until 2 hours before surgery. Patients will be given a Patient Information Form before surgery. Postoperative Recovery Index (Turkish Version), Visual Comparison Scale, Physiologic Parameters and Blood Glucose Monitoring Form and Number and Dosage of Antiemetic Drugs Taken in 24 Hours Postoperatively will be applied.

Control: No intervention Patients will be administered a Patient Information Form before surgery. Postoperative Recovery Index (Turkish Version), Visual Comparison Scale, Physiologic Parameters and Blood Glucose Monitoring Form and Number and Dosage of Antiemetic Drugs Taken in 24 Hours Postoperatively will be applied.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tuşba
      • VAN, Tuşba, Turkey, 065
        • Yasemin BOZKURT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • Planned coronary artery bypass graft surgery
  • Volunteering to participate in the research

Exclusion Criteria:

  • Under 18 years of age
  • Not planned coronary artery bypass graft surgery
  • Not volunteering to participate in the research
  • Cases received as an emergency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral carbohydrate solution was administered preoperatively
The experimental group will be given 800 ml of ora carbohydrate solution until midnight before surgery and 400 ml 2 hours before surgery. Patient Information Form will be collected from the patients before surgery. After the surgery, the Visual Comparison Scale, Physiological Parameters and Blood Glucose Monitoring, Form Postoperative Recovery Index (Turkish Version), and the Number and Dosage of Antiemetic Drugs Taken in the Postoperative 24 Hours form will be used.
Oral carbohydrate solution will be administered to patients before coronary artery bypass graft operation and its effects on postoperative nausea-vomiting, hunger, thirst, physiological parameters and recovery will be evaluated.
Placebo Comparator: Flavored Water Applied Before Surgery
The placebo group will receive 800 ml of flavored water until midnight before surgery and 400 ml 2 hours before surgery. A Patient Information Form will be collected from the patients before surgery. After the surgery, the Visual Comparison Scale, Physiological Parameters and Blood Glucose Monitoring Form, Postoperative Recovery Index (Turkish Version) and the Number and Dosage of Antiemetic Drugs Taken in 24 Hours Postoperatively will be used.
The effects of flavored water given to patients before coronary artery bypass graft operation on postoperative nausea-vomiting, hunger and thirst,
No Intervention: No Preoperative Intervention
No intervention will be made to patients who will undergo surgery. Patient Information Form will be collected from the patients before surgery. After the surgery, the Visual Comparison Scale, Physiological Parameters and Blood Glucose Monitoring Form, Postoperative Recovery Index (Turkish Version) and the Number and Dosage of Antiemetic Drugs Taken in 24 Hours Postoperatively will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Information Form
Time Frame: Up to 24 weeks
The personal information form used in the data collection process consists of demographic characteristics of the individuals such as age, gender, marital status, occupation, educational status and employment status, as well as health-related conditions of the patients such as chronic diseases and past surgical history.
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Recovery Index (Turkish Version)
Time Frame: Up to 24 weeks
The Postoperative Recovery Index (PRAI) used in the validity and reliability study conducted by Butler et al. (2012) consists of 25 items. This index includes psychological symptoms, physical activities, general symptoms, bowel symptoms and craving symptoms. In scoring the questionnaire, the scores of the items in each subscale are summed and a subscale score is obtained by taking the arithmetic mean. The ASI overall questionnaire score is calculated by taking the arithmetic mean of the total score over 25 items. Higher scores on the index indicate that postoperative recovery is more difficult and lower scores indicate that recovery is easier. The minimum score value in each parameter of this scale is 0 and the maximum score value is 5. In this study, the Cronbach's alpha coefficient of the ASIQ was 0.97, 0.90 for the psychological symptoms subscale, 0.83 for the physical activity subscale and 0.98 for the discomfort subscale.
Up to 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Dosage of Antiemetic Drugs Taken in 24 Hours Postoperatively
Time Frame: Up to 24 weeks
This questionnaire was used to assess the dose and number of antiemetic drugs used in the postoperative period. This questionnaire was used to measure patients' nausea and vomiting in the postoperative period. Scoring was evaluated on a scale of 0-10. The closer the score range was to 10, the higher the discomfort rate of the patients, while a score range closer to 0 indicated less discomfort.
Up to 24 weeks
Physiological Parameters and Blood Glucose Monitoring Form
Time Frame: Up to 24 weeks
This form is a comprehensive tracking tool for monitoring patients' vital signs. It includes regular recording of important parameters such as blood pressure, pulse rate, respiratory rate, oxygen saturation, body temperature and blood sugar. These regular measurements allow monitoring changes in the surgical process and the recovery process. The optimal value range of blood pressure is 120/80 mg/dl, pulse rate range is between 60-100 per minute, respiratory rate optimal value is between 12-20 per second, oxygen saturation optimal value is between 95-100, body temperature value is between 36-37'C, and blood glucose value is close to 90-140 values are close to the optimal value and the effect of oral carbohydrate solution on postoperative physiological parameters is positive.
Up to 24 weeks
Visual Benchmark Scale
Time Frame: Up to 24 weeks
This scale is used to measure various parameters such as hunger, thirst, nausea and vomiting. The scale value ranges from 0 to 10, with an increase in value indicating an increase in the relevant parameters. The minimum score on this scale is 0 and the maximum score is 10.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Actual)

March 10, 2024

Study Completion (Actual)

August 8, 2024

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Ybozkurt

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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