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

NCT ID: NCT06266481

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Postoperative Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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dexamethasone group

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

Group Type ACTIVE_COMPARATOR

Topical dexamethasone

Intervention Type 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

10% lidocaine was sprayed over the tube

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pharos University in Alexandria

OTHER

Sponsor Role lead

Responsible Party

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mona elsaid

lecture

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pharos University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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MONA el. Mssoud, ph anesthesia

Role: CONTACT

002+01005542232

hatem a. attallah, ph anesthesia

Role: CONTACT

8000000000

Facility Contacts

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mona el. massoud, ph anesthesia

Role: primary

002+01005542232

hatem a. attalla, ph anaesthesia

Role: backup

002+1001445568

References

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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.

Reference Type RESULT
PMID: 28184268 (View on PubMed)

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.

Reference Type RESULT
PMID: 26082898 (View on PubMed)

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.

Reference Type RESULT
PMID: 37675167 (View on PubMed)

Other Identifiers

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pua04202312313157

Identifier Type: -

Identifier Source: org_study_id

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