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

February 15, 2024 updated by: mona elsaid, Pharos University in Alexandria

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Alexandria, Egypt, 21348
        • Recruiting
        • Pharos university
        • Contact:
        • Contact:
        • Principal Investigator:
          • mona el. massoud, lecture

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexamethasone group
An endotracheal tube was soaked in 8mg of dexamethasone for group I intubation
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.
Active Comparator: lidocaine group
10% lidocaine was sprayed over the tube
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study
Time Frame: 3MONTH
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharos University in Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pua04202312313157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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