Clinical trial

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

Name

pua04202312313157

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.

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-04-30

Trial end

2024-05-30

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

dexamethasone group

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

Arms:

lidocaine group

Size

100

Primary endpoint

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

3MONTH

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-02-20

1 organization

2 products

1 indication

Organization

Pharos University in Alexandria

Product

Dexamethasone

Indication

Postoperative Sore Throat

Product

Lidocaine