Prevention of Post Operative Sore Throat: Comparing Intravenous Lidocaine, Intra-Cuff Alkalinized Lidocaine and Placebo. A Randomized Controlled Trial.

Not Applicable

• Conditions: Anaesthesia

• Registration Number: PACTR202009875831645
• Lead Sponsor: CHU Habib bourguiba Sfax

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Age above 18 years old.
-Patients receiving elective visceral, urologic, orthopedic or plastic surgeries.
-American Society Of Anesthesiologists (ASA) score of 1, 2 or 3.
-Easy predicted intubation.
-Intubation time estimated equal or less than 240 minutes.

Exclusion Criteria

-Patient’s refusal.
-Rapid sequence induction (RSI)
-Predicted airway management difficulty.
-Patient’s history of recent airway inflammation, injury or tumor.
-Contraindication for the use of drugs necessary for the protocol.
-ASA score of more than 3.
-Intubation time estimated more than 240 minutes.
-Use of supra-glottic tools for airway management.
-Laparoscopic surgery.
-Intubation time more than 240 minutes.
-Airway management difficulty.
-Traumatic airway management.
-Accidental extubation.
-Per-operative or recent re-intubation.
-Broncho / laryngospasm.
-Per-operative anaphylactic or allergic reaction.
-Use of corticosteroids.
-Anesthetic-protocol modifications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We evaluated the incidence of sore throat at the sixth then twenty-fourth post-operative hour as a primary outcome. Patients had to answer to a YES” or NO” question: do you feel having a sore throat?”. Throat pain was quantified using the Visual Analogic Scale (VAS): VAS had to be above 10 out of 100 to confirm a Yes” answer.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic variations during orotracheal intubation and extubation:;The incidence of cough at orotracheal intubation and emergence of anesthesia.;The incidence of cough at the 6th and 24th post-operative hours;The incidence of dysphonia at the 6th and 24th post-operative hours;The incidence of dysphagia at the 6th and 24th post-operative hours;The incidence of nausea and vomiting at the 6th and 24th post-operative hours