Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study

NCT06266481 | Recruiting Phase 2 DMC

• 1 other identifier: pua04202312313157
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.

Conditions

Postoperative Sore Throat

Keywords

Sore-throat postoperative; dexamesthsone; 10% lidocaine

Outcome Measures

Primary Outcomes (1)

• Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study

  This study aimed to compare the effectiveness of topical applications of dexamethasone versus lidocaine spray in prevention sore throat.Patients will be assessed at 1 and 6 h after extubation for post-operative sore throat (POST). POST will be assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness.

  3MONTH

Study Arms (2)

dexamethasone group

ACTIVE COMPARATOR

An endotracheal tube was soaked in 8mg of dexamethasone for group I intubation

Drug: Topical dexamethasone

lidocaine group

ACTIVE COMPARATOR

10% lidocaine was sprayed over the tube

Drug: 10% lidocaine was sprayed over the tube for the second group

Interventions

Topical dexamethasone DRUG

Patients were interviewed at 1 and 6 h after extubating for post-operative sore throat (POST). POST was assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness.

dexamethasone group

10% lidocaine was sprayed over the tube for the second group DRUG

Patients were interviewed at 1 and 6 h after extubating for post-operative sore throat (POST). POST was assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness.

lidocaine group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients belonging to ASA physical status I, II
• Patients between age18 to 50 years
• Patients belonging to both genders.
• patients undergoing shoulder arthroscopic surgeries.
• Patients with fasting blood glucose \<100 mg/dl or random blood sugar \<140 mg/dl.

You may not qualify if:

• Patients who are not willing to give consent for participation in the study
• Patients with anticipated difficult airway
• Patients who are allergic to steroids.
• Patients with ASA physical status III, IV
• Diabetic patients.
• Patients on steroids
• Patients requiring nasogastric tube or throat pack.
• Patients posted for head and neck surgeries.
• patient with GERD
• Pregnant patients
• preexisting upper respiratory tract infection.

Sponsors & Collaborators

• Pharos University in Alexandria: lead

Study Sites (1)

Pharos University

Alexandria, 21348, Egypt

RECRUITING

Related Publications (3)

• Lee JH, Kim SB, Lee W, Ki S, Kim MH, Cho K, Lim SH, Lee KM, Choi DN, Oh M. Effects of topical dexamethasone in postoperative sore throat. Korean J Anesthesiol. 2017 Feb;70(1):58-63. doi: 10.4097/kjae.2017.70.1.58. Epub 2016 Nov 25.

  PMID: 28184268 RESULT

• Banihashem N, Alijanpour E, Hasannasab B, Zarei A. Prophylactic Effects of Lidocaine or Beclomethasone Spray on Post-Operative Sore Throat and Cough after Orotracheal Intubation. Iran J Otorhinolaryngol. 2015 May;27(80):179-84.

  PMID: 26082898 RESULT

• Jabbar ML, Mahboba JH, Meazher N. Comparing the effectiveness of topical dexamethasone emollient, lidocaine gel, and glycerin emollient on the endotracheal tube for postoperative hoarseness of voice, sore throat, and laryngospasm. J Med Life. 2023 Jun;16(6):904-907. doi: 10.25122/jml-2022-0137.

  PMID: 37675167 RESULT

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

MONA el. Mssoud, ph anesthesia

CONTACT

002+01005542232; mona.elsaid@pua.edu.eg

hatem a. attallah, ph anesthesia

CONTACT

8000000000; hatattalla@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)