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Postoperative PainNCT06271161

The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting

An observational study of Postoperative Pain and Postoperative Nausea and Vomiting, run by Selcuk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2023to 1 Jan 2024
How long will I take part?
10 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 84 patients who were older than 18 years of age and had ASA (American Society of Anesthesiologists) physical status classification I - II, who underwent outpatient dental surgical procedures under general anesthesia.

Who may be able to join

  • > 18 year old
  • ASA I-II
  • Apfel Score<2

Who cannot join

  • Clinical diagnosis of motion sickness
  • Clinical diagnosis of malignancy
  • Clinical diagnosis of upper respiratory tract infection in last 2 weeks
  • Clinical diagnosis of any bleeding disorders
  • Patient that couldn't be intubated at first attempt

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Funda Arun

    Selçuklu, Konya, 42000

Other trials in Turkey (Türkiye)

About this study

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?

Read the detailed 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.

Medical subject headings
Pain, Postoperative, Postoperative Nausea and Vomiting, Pharyngitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used.

    The incidence of postoperative throat pain (POTP) was recorded with the following 100 mm VAS scale: 0, no POTP; 1-3, mild POTP (complaining of throat pain only when asked); 4-7, moderate POTP (complaining of throat pain spontaneously); and 8-10, severe POTP (presence of voice change or hoarseness accompanying throat pain). Additionally, the incidence of postoperative nausea and vomiting (PONV) was assessed at the 5th, 10th, and 30th minutes, as well as at the 1st, 2nd, and 6th hours, using the following Myles's simplified PONV impact scale (score > 0 is regarded as the occurrence of PONV, vomited or dry-retching (0-3 score) and nausea (0-3 score) ,with higher scores indicating being more severe.

    Measured: 1 month

Secondary outcomes (1)
  1. Intraoperative change in nasopharyngeal temperature from baseline (ºC ), intraoperative opioid usage (mcg), postoperative analgesic usage (mg),antiemetic usage(mg) and any adverse events due to throat pack were recorded.

    During the surgery, the patient's nasopharyngeal temperature(ºC ), total doses of opioid drugs used (mcg), analgesic and antiemetic drug use (yes/no) in the postoperative recovery room, and the presence/absence of any undesirable events related to the throat pack were recorded.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start1 Jan 2023
  3. Primary completion1 Nov 2023
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
84 participants (actual)
Target duration
10 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06271161
Sponsor's protocol ID
F002
Status last verified
Feb 2024
First submitted
25 Jan 2024
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain and Postoperative Nausea and Vomiting, run by Selcuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used. (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.

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