Clinical trial NCT06122324: Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat
Official title: Evaluation of the Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Sore Throat
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 patients aged 18-65 with ASA 1-3 classification will participate in the study, undergoing elective laparoscopic cholecystectomy.

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* electively laparoscopic cholecystectomy.

  * ASA I-III,
  * between 18-65 years

Exclusion Criteria:

* ASA IV and above

  • over 65 - under 18 years of age
* lidocaine allergy

Primary outcomes:
measure: The effect of lidocaine on postoperative sore throat
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Effect of lidocaine on hemodynamic response
timeFrame: perioperative
Other outcomes:
Locations:
city: Kadiköy
country: Turkey
facility: University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital
state: İ̇stanbul
Study officials:
affiliation: Kartal Dr Lutfi Kırdar City Hospital
name: hülya yılmaz ak
role: PRINCIPAL_INVESTIGATOR
References: