Clinical trial NCT05317520: The Effect of Cold Vapor Application on Postoperative Sore Throat
Official title: The Effect of Cold Vapor Application on Sore Throat in The Patients Extubated After Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore Throat
Keywords: Extubation
Sore throat
Cold vapor
Nursing
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were divided into intervention and control groups using a simple randomized control method.
Primary purpose: PREVENTION

Brief summary: To determine the effect of cold vapor given in the post-extubation period on sore throat.

Detailed description: General anesthesia increases the comfort of the patient by ensuring that the patient does not feel the surgical interventions and pain during the operation. The necessity of intubation is known in patients who have undergone surgery under general anesthesia. Intubation provides benefits such as keeping the airway open, controlling the airway and breathing, reducing respiratory effort and dead space volume, preventing aspiration, and facilitating resuscitation in case of any problem.

Although surgical interventions are an important treatment option for health problems, postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in patients receiving general anesthesia.

Although it is seen in the literature that pharmacological, non-pharmacological and herbal methods are applied to reduce postoperative sore throat, there are not enough studies examining the effect of cold steam application on sore throat. With this research, it is expected that the cold steam given in the postoperative period will contribute to the relief of sore throat.

Eligibility criteria: Inclusion Criteria:

* Those who accept the research
* Elective laparoscopic cholecystectomy surgery planned
* Patients in ASA I and II class
* 18 years and over
* Mallampati classification I and II
* Operation time more than 30 minutes
* Literate
* No hearing problem
* Patients without understanding difficulties

Exclusion Criteria:

* Overweight patients (Body Mass Index ≥ 40)
* Patients with sore throat and lower respiratory tract infection
* Patients with Chronic Obstructive Pulmonary Disease (COPD)
* Patients with a history of allergies
* Patients with hearing problems
* illiterate patients
* ASA classification III and above
* Mallampati classification III and IV patients
* Patients with an operation time of less than 30 minutes

Primary outcomes:
measure: Sore throat
timeFrame: Within an hour after surgery
measure: Sore throat
timeFrame: 2nd hour after surgery
measure: Sore throat
timeFrame: 6th hour after surgery
measure: Sore throat
timeFrame: 24th hour after surgery
Secondary outcomes:
measure: Hoarseness
timeFrame: Within an hour after surgery
measure: Hoarseness
timeFrame: 2nd hour after surgery
measure: Hoarseness
timeFrame: 6th hour after surgery
measure: Hoarseness
timeFrame: 24th hour after surgery
measure: Dry throat and swallowing difficulty
timeFrame: Within an hour after surgery
measure: Dry throat and swallowing difficulty
timeFrame: 2nd hour after surgery
measure: Dry throat and swallowing difficulty
timeFrame: 6th hour after surgery
measure: Dry throat and swallowing difficulty
timeFrame: 24th hour after surgery
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Hatice Özsoy
state: Burdur
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Hatice Özsoy
role: PRINCIPAL_INVESTIGATOR
References: