Nausea Clinical Trial
Official title:
The Effect on Thirst, Nausea-Vomiting, Hemodynamic Parameters, and Comfort Levels of Menthol Lozenge Applied After Extubation to Patients to Undergoing Cardiovascular Surgery
NCT number | NCT04994262 |
Other study ID # | 21-14 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | May 1, 2021 |
Verified date | August 2021 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is reported that approximately 17.5 million people die worldwide each year due to cardiovascular diseases, including ischemic heart disease, cerebrovascular disease and rheumatic heart disease. The most preferred method in the treatment of coronary artery disease is Coronary Artery Bypass Graft (CABG) surgery. This procedure routinely requires general anesthesia and endotracheal intubation. Patients due to these practices often experience nausea-vomiting and thirst after extubation. It is stated that menthol application, which is a low cost, easy to apply and safe method, can be effective in the management of these complications. As a result of the literature review, there is no study evaluating the effectiveness of the menthol lozenge in quenching thirst after extubation and in the management of nausea and vomiting. In this study, it is aimed to develop methods that accelerate the postoperative recovery by proving the effect of oral menthol lozenge intake after extubation on thirst, nausea-vomiting, physiological parameters and comfort level in patients undergoing CABG surgery. The universe of this randomized controlled study was planned by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital will create patients who underwent CABG surgery. His sample, on the same dates, was Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital will create a total of 118 patients hospitalized in the Cardiovascular Surgery (Postoperative) Intensive Care Unit and undergoing CABG surgery that meet the inclusion criteria. Participants will be divided into two equal groups as intervention (n = 59) and control (n = 59) groups. Patient Information Form, Intraoperative Patient Evaluation Form, Visual Analogue Scale (VAS) for evaluation of thirst and nausea-vomiting, Physiological Parameter Control Form, Analgesic-Antiemetic Use Control Form, General Comfort Scale Short Form will be used for data collection. The intervention group will be given a lozenge containing menthol orally at the 30th, 60th and 90th minutes after extubation. Thirst, nausea-vomiting, physiological parameters, analgesic and antiemetic consumption and comfort levels of all patients will be evaluated. The data obtained from the study will be analyzed with appropriate statistical methods using the SPSS for Windows 22.0 program (Statistical Package for the Social Sciences).
Status | Completed |
Enrollment | 118 |
Est. completion date | May 1, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - between the ages of 18-65 - Undergoing elective coronary artery bypass graft surgery - Extubated within the first 8 hours in the intensive care unit after CABG surgery - Class ASA I, II and III - Mallampati classification I and II - Have no swallowing difficulties and Mann swallowing assessment score =95 - Glasgow Coma Scale with 15 points - Patients who agree to participate in the study will be included. Exclusion Criteria: - Body Mass Index of 40 - Have a history of allergies - Having severe nausea and vomiting at the time of application Illiterate - Having communication problems - Patients with psychiatric problems and using drugs will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Selma CAN | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) for Evaluating Thirst Level | The VAS is 10 cm long and graded on a horizontal line.
Thirst Score Comment: 0-3 points Mild Thirst 4-6 points Moderate Thirst 7-10 points Severe Thirst |
Change from baseline (30 minutes) thirst level at 120 minutes after extubation. | |
Primary | Visual Analogue Scale (VAS) for Evaluation of Nausea and Vomiting | It is used to convert numerically non-measurable values into a numerical state. Interpretation of nausea severity score averages
Nausea Severity Interpretation: 0-1 No nausea 2-4 Mild nausea 5-7 Moderate nausea 8-10 Severe nausea |
Change from baseline (30 minutes) nausea and vomiting at 120 minutes after extubation. | |
Primary | General Comfort Scale Short Form (GAS-SF) | The sc items), relaxation (9 items), and overcoming problems (10 items). In the evaluation of the scale consisting of positive and negative items, negative items are summarized with reverse coding. The lowest possible value of 1 indicates low comfort, and the highest value of 6 indicates high comfort.ale includes the sub-dimensions of relaxation, relaxation (9 | This test will be applied on the second day after the surgery. |
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