Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

Postoperative Sore Throat Clinical Trial

Official title:

Evaluation of the Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06122324
• Other study ID #: kartalanesthesia
• Status: Enrolling by invitation
• Start date: October 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Postoperative Sore Throat

Intervention

Drug:
• Lidocaine Hydrochloride
Patients in Group 1 will receive 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation.

Locations

Country	Name	City	State
Turkey	University of Health Science, Kartal Dr Lütfi Kirdar Training and Research Hospital	Kadiköy	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of lidocaine on postoperative sore throat	The primary outcome of the study is to demonstrate whether lidocaine reduces postoperative sore throat. Sore throat and hoarseness of the patients were also investigated and recorded at the postoperative 0th, 2nd, 4th, and 24th hours. Sore throat was assessed with a scale as 0: no sore throat; 1: minimal sore throat (complaints of sore throat only on question); 2: moderate sore throat (accompanying sore throat); and 3: severe sore throat (voice change or hoarseness related to sore throat).	postoperative 24 hours
Secondary	Effect of lidocaine on hemodynamic response	The secondary outcome of the study is to assess the impact of lidocaine on hemodynamic response. Before induction, after induction, after intubation at 1st and 5th minutes, and postoperative heart rate increase and blood pressure increase will be evaluated.	perioperative