The Effect on Thirst, Nausea-Vomiting and Comfort Levels of Menthol Lozenge Applied After Extubation
Condition: Nausea; Vomiting; Thirst
MeSH terms: Nausea; Vomiting
Study type: Interventional

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).
    

Detailed description: 
      The aim of this study is to determine the effect of oral menthol lozenge administered after
      extubation on thirst, nausea-vomiting, physiological parameters and comfort level, as well as
      analgesic and antiemetic consumption in patients who underwent cardiovascular surgery. With
      this research, it is aimed to increase patient comfort by providing evidence of the effect of
      low-cost oral menthol lozenge intake on the feeling of thirst, nausea-vomiting, analgesic and
      antiemetic integration after extubation on physiological parameters.

      Practices aimed at eliminating many problems such as thirst, sore throat, nausea and vomiting
      experienced in the early postoperative period positively affect the physical, psychospirical,
      environmental, sociocultural comfort of the patient and strengthen their health-oriented
      behaviors. It has been reported that there is a relationship between health-enhancing
      behaviors and providing comfort. It is observed that patients who undergo surgical procedures
      experience many problems in the postoperative period, their comfort level decreases and they
      are widely affected, from prolonged hospital stay to mortality. There are many studies in the
      literature aimed at accelerating the recovery in the perioperative process and increasing
      patient satisfaction.

      Complications such as thirst and nausea and vomiting, which are seen in the postoperative
      period and can be quite disturbing by patients, can be overlooked in clinical observations.
      It is planned to prove the effectiveness of the use of low-cost and easy-to-apply menthol
      lozenge in the management of these complications. In the light of the literature review,
      menthol was found to be effective in gastrointestinal system disorders, pain management, and
      dehydration. The use of oral menthol containing lozenge in quenching thirst after extubation,
      in the management of postoperative nausea and vomiting, and in improving patient comfort, as
      well as analgesic-antiemetic consumption and evaluation of physiological parameters are the
      original value of this study.

      The universe of the research was carried out 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.

      Sampling calculation was done with G Power 3.1.9.7 package program. Based on the VAS score
      averages in the study conducted by Aydın (2016), the sample that will represent the
      population was calculated as 0.05 significance level, the power of the study 80% and the
      effect size 0.46 (medium level) at the 95% confidence interval. As a result of the
      statistical analysis, it was calculated that the study should be carried out with a minimum
      of 118 patients, 59 in the experimental group and 59 in the control group.

      t tests - Means: Difference between two independent means (two groups) Analysis: A priori:
      Compute required sample size Input: Tail(s) = One Effect size d = 0.4617784 α err prob = 0.05
      Power (1-β err prob) = 0.80 Allocation ratio N2/N1 = 1 Output: Noncentrality parameter δ =
      2.5080987 Critical t = 1.6580957 Df = 116 Sample size group 1 = 59 Sample size group 2 = 59
      Total sample size = 118 Actual power = 0.8019408 Randomization Method: After obtaining the
      permission of the ethics committee, patients who meet the inclusion criteria in the study and
      who have received written informed consent to participate in the study will be divided into
      two groups in equal numbers with the computer-based randomization method.
    

Intervention name(s): Menthol Lozenge
Intervention type(s): Other
Intervention description(s): 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 MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Nausea; Vomiting; Menthol; Thirst; CABG