Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271161
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-01-25
Brief Title:
The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting
Sponsor:
Selcuk University
Organization:
Selcuk University
Study Overview
Official Title:
The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mgkg intravenous methylprednisolone and 40 mg pantoprozole were administered before surgery Anesthesia was induced with 3 mgkg iv sodium thiopental 06 mgkg iv rocuronium bromide and 1-15 mcgkg iv fentanyl and was maintained with 2 sevoflurane in 50 N2O50 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 patients 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 09 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
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 mgkg intravenous methylprednisolone and 40 mg pantoprozole were administered before surgery Anesthesia was induced with 3 mgkg iv sodium thiopental 06 mgkg iv rocuronium bromide and 1-15 mcgkg iv fentanyl and was maintained with 2 sevoflurane in 50 N2O50 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 patients 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 09 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None