The Effect on Thirst, Nausea-Vomiting and Comfort Levels of Menthol Lozenge Applied After Extubation

NCT04994262 | Completed

• 1 other identifier: 21-14
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Nausea; Vomiting; Thirst

Keywords

Nausea; Vomiting; Menthol; Thirst; CABG

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients in the intervention group will be given a lozenge with menthol at the 30th, 60th and 90th minutes after extubation and it will be explained that they should be dissolved in the mouth without swallowing, and the patients will be kept under observation during this time. Thirty, 60, 90, and 120 minutes after extubation: Patients' thirst level and severity of nausea will be evaluated with the Visual Analogue Scale (VAS) and the presence of vomiting will be questioned. In addition, its physiological parameters will be recorded. These parameters will be evaluated just before the menthol lozenge application at the 30th, 60th and 90th minutes. Sixty, 120, 180, and 240 minutes after extubation: The amount and types of analgesic and antiemetic usage of the patients will be recorded. Second postoperative day: The comfort level of the patients will be evaluated using the General Comfort Scale Short Form.

Other: Menthol Lozenge

Control Group

NO INTERVENTION

Patients in the control group will be followed up according to their routine clinical procedures. Since there is no procedure or intervention in the clinical procedures, only the patients will be followed up. Patients in the control group will be followed up with the same forms at the same time. Thirty, 60, 90, and 120 minutes after extubation: Patients' thirst level and severity of nausea will be evaluated with the Visual Analogue Scale (VAS) and the presence of vomiting will be questioned. In addition, its physiological parameters will be recorded. Sixty, 120, 180, and 240 minutes after extubation: The amount and types of analgesic and antiemetic usage of the patients will be recorded hourly. Second day after surgery: The comfort level of the patients will be evaluated and recorded using the General Comfort Inventory Short Form.

Interventions

Menthol Lozenge OTHER

In the study, "Oka Menthol", a herbal lozenge produced by Otacı, will be used. Its formula contains: menthol 0.26%, eucalyptol 0.065%, thymol 0.0002%, camphor 0.0002%, anise oil, thyme oil, coltsfoot, marshmallow flower, bovine tail flower extracts, glucose and sucrose. Medical properties: Otacı Oka Menthol Pastil shows antibacterial and fungicidal properties with eucalyptol in its composition. Menthol is effective against local anesthetic, local antitussive and irritation. It also plays a mild analgesic role with camphor in its content. It has an antibacterial and antifungal effect with thymol, a phenolic antiseptic. Otaco Oka Menthol Pastilles also contain extracts of coltsfoot, cow's tail flower and marshmallow flower which are anti-irritant and expectorant.

Intervention Group

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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Selma CAN

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: August 6, 2021
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)