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

Postoperative Sore Throat Clinical Trial

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Official title:

Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce Post-intubation Sore Throat in Shoulder Arthroscopic Surgeries: A Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266481
• Other study ID #: pua04202312313157
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 1, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2024
• Source: Pharos University in Alexandria
• Contact: MONA el. Mssoud, ph anesthesia
• Phone: 002+01005542232
• Email: mona.elsaid[@]pua.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.In this study, 100 patients were intubated to undergo general anaesthesia for shoulder arthroscopy and randomised into one of two groups. An endotracheal tube was soaked in 8mg of dexamethasone for the first group intubation, while 10% lidocaine was sprayed over the tube for the second group. Following extubation, the two groups examined the severity of sore throats

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• •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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pharyngitis
• Postoperative Sore Throat

Intervention

Drug:
• Topical dexamethasone
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.
• 10% lidocaine was sprayed over the tube for the second group
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.

Locations

Country	Name	City	State
Egypt	Pharos University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Pharos University in Alexandria

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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( — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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