Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06122324 |
| Other study ID # |
kartalanesthesia |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Dr. Lutfi Kirdar Kartal Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Postoperative sore throat (POST) is a common outcome of general anesthesia in patients who
undergo endotracheal intubation, and the estimated risk varies between 14.4% and 62%. It is
one of the most undesirable postoperative anesthesia complications and has a negative impact
on patient satisfaction and quality. Mucosal damage, inflammation, and erosion caused by
endotracheal intubation all contribute to the development of POST. Therefore, POST is a
condition that requires prevention and improvement.
In the study, patients will be divided into two groups. The investigators will include 100
patients undergoing surgery under general anesthesia. The first group will receive 40 mg of
lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will
receive standard anesthesia management as the control group.
Throat pain assessment will be conducted in patients at 2, 6, 12, and 24 hours after surgery.
Description:
Between November 2023 and December 2023, a total of 100 patients aged 18-65 with ASA 1-3
classification who are electively scheduled for laparoscopic cholecystectomy will participate
in the study. Patients with ASA 4 or higher, those aged 65 and older, those under 18, and
individuals with a known allergy to local anesthesia will not be included in the study.
Patients who require intubation and are admitted to the intensive care unit or who experience
mortality will be excluded from the study.
All patients will undergo preoperative assessment one day before the surgery, and written
informed consent will be obtained for participation in the study. Patients will be randomly
assigned to groups using a computer-generated randomization table. Patients in Group 1 will
receive 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation, while the
second group will receive standard anesthesia management as the control group.
Demographic data, medical history, American Society of Anesthesiologists (ASA)
classification, and pre- and post-lidocaine administration cardiac output (CO) and oxygen
consumption (VO2), anesthesia time, surgical duration, as well as the occurrence of
postoperative hypotension (systolic blood pressure decreased by more than 20% from baseline
or SBP < 80 mmHg during surgery), nausea and vomiting, hypoxemia (SpO2 < 90% or PaO2 < 60
mmHg), hypercapnia (PaCO2 > 45 mmHg), and agitation during the awakening period will be
recorded.
Throat pain will be assessed and recorded at postoperative hours 2, 6, 12, and 24. Throat
pain will be evaluated using a throat pain scoring system ranging from 0 (no pain) to 3
(worst imaginable pain). After the surgery, all patients will be transferred to the
post-anesthesia care unit (PACU).
