Effect of Clove Oil and Menthol Lozenges on Post-extubation Sore Throat

Atlas University

Status and phase: Invitation-only; Early Phase 1

Conditions: Sore Throat

Treatments: Biological: Menthol lozenge; Biological: Clove lozenge; Other: None-placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06811051

CToprak

Details and patient eligibility

About

In patients undergoing surgical intervention, endotracheal intubation, which is a part of the anesthesia procedure, can cause postoperative sore throat in patients. This situation causes difficulty in swallowing, inadequate nutrition and fluid intake, and prolongs the recovery process. In addition, sore throat is defined as a source of physical stress, which can lead to an increase in the incidence of postoperative morbidity and a decrease in patient satisfaction. This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat after surgery. Our aim was to provide evidence on the effectiveness of simple, low-cost menthol and clove oil lozenges in reducing sore throat after extubation, thus helping the patient recover.

Full description

This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat in patients after surgery.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being between the ages of 18-65. Having had abdominal surgery. Being extubated within the first 8 hours after surgery. ASA class I-III. Mallampati class I-II. Glasgow Coma Scale (GCS) score 15

Exclusion criteria

• History of allergies.

  • Severe nausea and vomiting.
  • Being extubated after the first 8 hours after surgery.
  • Communication disorders
  • Mallampati class III-IV.
  • Glasgow Coma Scale (GCS) score <15

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Menthol Group Patients

Experimental group

Description:

Patients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.

Treatment:

Biological: Menthol lozenge

Clove lozenge group

Experimental group

Description:

Patients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.

Treatment:

Biological: Clove lozenge

Control Group

Placebo Comparator group

Description:

Before routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated.

Treatment:

Other: None-placebo