Abstract Objective:
The aim of this study is to compare two different ways of adjusting the air-filled cushion (cuff) of the breathing tube used during general anesthesia in children undergoing laparoscopic appendectomy (closed surgery for appendicitis). The goal is to see if maintaining the pressure in this cushion within a safe, specific range (15-18 mmHg) helps prevent or reduce sore throat, hoarseness, and discomfort, which are common postoperative complications in children.
Study Design:
This is a prospective, randomized, controlled study. Sixty children aged 6 to 18 years scheduled for laparoscopic appendectomy will be included. Participants will be randomly assigned to two equal groups: Group A (Control Group): Breathing tube cuff pressure is adjusted using the standard "feeling" (finger palpation) method common in routine practice. Group B (Intervention Group): Breathing tube cuff pressure is measured throughout the surgery using a medical pressure sensor (manometer) and maintained within a safe range (15-18 mmHg). Research Questions: Does actively monitoring airway pressure reduce the number of children experiencing postoperative sore throat? Does this method reduce the severity of sore throat, cough, hoarseness, or other respiratory discomfort compared to the standard method? What will happen?
During surgery, respiratory and heart rate measurements will be recorded every 15 minutes for all participants. After surgery, researchers will visit participants (and their parents) at 2, 6, and 24 hours postoperatively to assess the presence of sore throat, discomfort, or hoarseness. No additional medications or invasive procedures will be used for this study; only how we manage airway pressure will be compared.
Pediatric patients aged 6-18 years
Patients with ASA physical status classification I-III
Patients scheduled for laparoscopic appendectomy
Voluntary written informed consent from the patient's legal guardian/parent after being informed in detail about the purpose and method of the study..
Patients under 6 years of age
Patients with ASA IV or higher
Patients with preoperative sore throat
Patients who have not completed the preoperative fasting period
Parallel
Pressure Transducer
DeviceIn this group of patients, endotracheal tube cuff pressure was continuously monitored using a pressure transducer from an invasive arterial pressure measurement set and maintained within a safe range (15-18 mmHg).
Traditional Palpation Method
Procedure/SurgeryThe endotracheal tube cuff pressure was adjusted by the anesthesiologist using the subjective manual palpation technique, where the pressure in the cuff was estimated by manually squeezing the pilot balloon. No external monitoring device was used in this group, reflecting the conventional clinical practice.
Incidence of Postoperative Sore Throat
The incidence of sore throat in patients during the first 24 hours after surgery will be evaluated and compared between groups. Sore throat is defined as pain or discomfort felt in the larynx or pharynx, often worsened by swallowing. It will be evaluated as yes/no.
Incidence of postoperative hoarseness.
The frequency of hoarseness will be assessed and compared between groups within the first 24 hours after surgery. Hoarseness will be defined as an abnormal change in the voice, such as the voice sounding breathy, muffled, strained, or a change in loudness or pitch. It will be evaluated as yes/no.
Intraoperative highest inspiratory pressure (Ppeak)
The highest inspiratory pressure (Ppeak) (mmHg) measured after intubation (T0), after pneumoperitoneum (T1), and every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te) will be recorded and compared between groups.
Frequency and severity of postoperative sore throat according to postoperative time.
Assessment of the presence and severity of sore throat after extubation. Severity is scored using a 4-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Comparisons will be made between groups after the assessment.
Frequency of Cough at Specific Time Points Postoperatively
Postoperative cough will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation. It will be evaluated as yes/no.
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