SurgeryNCT06788951
The Effect of Oral Carbohydrate Inhalation Given to Patients Before Coronary Artery Bypass Graft Operation on Recovery
A study testing administration of oral carbohydrate solution to patients before coronary artery bypass graft surgery and giving flavored water to patients before coronary artery bypass graft surgery in people with Surgery, run by Yasemin Bozkurt at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- administration of oral carbohydrate solution to patients before coronary artery bypass graft surgery and giving flavored water to patients before coronary artery bypass graft surgery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2024to 8 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Planned coronary artery bypass graft surgery
- Volunteering to participate in the research
Who cannot join
- Under 18 years of age
- Not planned coronary artery bypass graft surgery
- Not volunteering to participate in the research
- Cases received as an emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- administration of oral carbohydrate solution to patients before coronary artery bypass graft surgery, giving flavored water to patients before coronary artery bypass graft surgery
- Keywords
- Surgery, ERAS, Nursing, Cardiovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of oral carbohydrate solution to patients before coronary artery bypass graft surgeryDietary supplement
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.
giving flavored water to patients before coronary artery bypass graft surgeryOther
The effects of flavored water given to patients before coronary artery bypass graft operation on postoperative nausea-vomiting, hunger and thirst,
| Study group | Role | What they receive |
|---|---|---|
| Oral carbohydrate solution was administered preoperatively | Experimental | 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. Receives: Dietary Supplement: administration of oral carbohydrate solution to patients before coronary artery bypass graft surgery |
| Flavored Water Applied Before Surgery | Placebo comparator | 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. Receives: Other: giving flavored water to patients before coronary artery bypass graft surgery |
| No Preoperative Intervention | No 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 being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
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.
Measured: Up to 24 weeks
Secondary outcomes (1)
Postoperative Recovery Index (Turkish Version)
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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start8 Mar 2024
- Primary completion10 Mar 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasemin Bozkurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasemin Bozkurt, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788951
- Sponsor's protocol ID
- Ybozkurt
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06788951
- Acronym / sponsor ID
- Ybozkurt
- Conditions
- Surgery
- Keywords
- Surgery, ERAS, Nursing, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yasemin BozkurtUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral carbohydrate solution was administered preoperatively | Experimental | Dietary Supplement: administration of oral carbohydrate solution to patients before coronary artery bypass graft surgeryThe 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. |
| Flavored Water Applied Before Surgery | Placebo comparator | Other: giving flavored water to patients before coronary artery bypass graft surgeryThe 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. |
| No Preoperative Intervention | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Planned coronary artery bypass graft surgery
- Volunteering to participate in the research
Key exclusion criteria (4 listed)
- Under 18 years of age
- Not planned coronary artery bypass graft surgery
- Not volunteering to participate in the research
- Cases received as an emergency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administration of oral carbohydrate solution to patients before coronary artery bypass graft surgeryOral 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. | Dietary supplement | Oral carbohydrate solution was administered preoperatively |
| giving flavored water to patients before coronary artery bypass graft surgeryThe effects of flavored water given to patients before coronary artery bypass graft operation on postoperative nausea-vomiting, hunger and thirst, | Other | Flavored Water Applied Before Surgery |
Primary outcome
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.
1 secondary outcome
Postoperative Recovery Index (Turkish Version)
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of oral carbohydrate solution to patients before coronary artery bypass graft surgery and giving flavored water to patients before coronary artery bypass graft surgery in people with Surgery, run by Yasemin Bozkurt at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.