Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06271161 |
| Other study ID # |
F002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Selcuk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The goal of this observational study is to to evaluate the effects of a throat pack soaked
with saline at +4 ºC on postoperative throat pain (POTP) and postoperative nausea and
vomiting (PONV) in dental surgical procedures performed under general anesthesia. The main
questions it aims to answer are: 1. How long can we keep the pharyngeal mucosa cold using
tampons and cold wash solutions? 2. Does cooling the pharyngeal mucosa reduce the incidence
of postoperative sore throat and nausea and vomiting?
Description:
The study included 84 ASA I - II patients, over 18 years of age, who would undergo outpatient
surgery under general anesthesia in the operating room of Selçuk University Faculty of
Dentistry. Apfel score was used to classify patients according to PONV risk. Patients with
Apfel scores of 0, 1 and 2 were included in the study. Patients with a history of difficult
intubation, patients who could not be intubated at the first attempt, patients with bleeding
disorders, motion sickness, malignancy, and patients who had an upper respiratory tract
infection in the last 2 weeks were excluded from the study.
The patients were not prescribed any analgesics or anxiolytics before surgery. Pulse oximetry
(SpO2), electrocardiogram (ECG), non-invasive blood pressure and end-tidal CO2 pressure
(PETCO2) and nasopharyngeal temperature measurement (T), which are standard monitoring
methods in general anesthesia applications, were applied to all patients and the values were
recorded every 5 minutes. Each patient was administered IV cannulation over the right hand
and 1 mg/kg intravenous methylprednisolone and 40 mg pantoprozole were administered before
surgery. Anesthesia was induced with 3 mg/kg iv sodium thiopental, 0.6 mg/kg iv rocuronium
bromide and 1-1.5 mcg/kg iv fentanyl, and was maintained with 2% sevoflurane in 50% N2O/50%
O2. All patients were given appropriate head and neck position before surgery, after nasal
intubation with an endotracheal tube (ETT) with lubricating gel applied to the cuff, with the
help of a videolaryngoscope. ETT cuff pressure was kept within the range of 20-30 cm H2O with
the help of a manometer (VBM, Sultz, Germany) throughout the surgery. The patient's body
temperature was monitored by placing a reusable temperature probe into the nasopharynx and
recorded during the operation. A throat tampon made of 20x10 cm diameter gauze soaked in
saline at +4 ºC was gently placed into the oropharynx by the anesthetist and surgical
procedures were initiated.
Demographic data of the patients included in the study such as age, gender, weight, Apfel
scores, total doses of opioid drugs used in anesthesia, anesthesia-related data such as ASA
score, endotracheal tube diameter, and surgical procedure-related data such as surgical time,
surgical procedure, and amount of bleeding were recorded.
During the surgery, the operating room temperature was kept between 22 ºC and 24 ºC. The
amount of saline at +4 ºC used to wash the oral cavity during surgical procedures was
recorded. At the conclusion of the surgical procedures, the neuromuscular blockade was
reversed and the tampon was gently removed by the same anesthesiologist before extubation.
All patients were administered IV 50 mg Dexketoprofen just before waking up from general
anesthesia.
All patients in the study were extubated and taken to the recovery room. Nausea, vomiting,
and sore throat were recorded at the 5th, 10th, and 30th minutes, and at the 1st, 2nd, and
6th hours postoperatively by a surgical assistant who was blinded to the study. IV 20 mg
metoclorpamide was used as rescue antiemetic. For pain scores higher than POBA 4, 75 mg
tramadol in 100 ml 0.9% saline was administered as a 10-minute IV infusion. Analgesic and
antiemetic drug use was recorded as present or absent. All patients were discharged on the
day of surgery.
