Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of

Cough Clinical Trial

Official title:

Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114021
• Other study ID #: 08/13/1019
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2014
• Last updated: April 14, 2014
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics committee of Islamic Azad University
• Study type: Interventional

Clinical Trial Summary

ABSTRACT:

The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran.

99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients.

For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

1. 50 years<age>15 years

2. no acute upper respiratory infections and no sore throat

3. candidate for elective surgery unrelated to the throat

4. The lack of airways difficulties

5. candidate for general anesthesia with intubation

6. no contraindications for receiving steroid

7. surgery time < 240 minutes

8. intubation up to 2 times

9. tracheal tube cuff pressure = 25-30 cm H2o

10. fasting for 8-6 hours prior to surgery

11. ASA I and ASAII and

12. Surgery under general anesthesia and endotracheal intubation

Exclusion Criteria:

1. use of nasogastric tube or throat packs

2. patients with upper respiratory tract infection

3. patients on steroid therapy were excluded from the study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough
• Dysphonia
• Hoarseness
• Pharyngitis
• Sore Throat

Intervention

Drug:
• betamethasone gel
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
• lidocaine jelly
the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
• distilled water
The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Anesthesiology, Booali Hospital, Islamic Azad University,	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sore throat	For the all the patients, the incidence of postoperative cough in 24 hours follow-up based on the different types of medications were obtained (using questionnaire).	24 hours after surgery	Yes
Primary	cough	For the all the patients, the incidence of postoperative cough in 1 hour follow-up periods based on the different types of medications were obtained (using questionnaire).	1 hour after surgery	Yes
Primary	hoarseness of voice	For the all patients, the incidence of postoperative hoarseness of the voice in 1 hour follow-up period based on the different types of medications were obtained (using questionnaire).	1 hour after surgery	Yes
Primary	sore throat	For the all the patients, the incidence of postoperative cough in 1 hour follow up based on the different types of medications were obtained (using questionnaire).	1 hour after surgery	Yes
Primary	sore throat	For the all the patients, the incidence of postoperative cough in 6 hours follow-up based on the different types of medications were obtained (using questionnaire).	6 hours after surgery	Yes
Primary	cough	For the all the patients, the incidence of postoperative cough in 6 hours follow-up periods based on the different types of medications were obtained (using questionnaire).	6 hours after surgery	Yes
Primary	cough	For the all the patients, the incidence of postoperative cough in 24 hours follow-up periods based on the different types of medications were obtained (using questionnaire).	24 hours after surgery	Yes
Primary	hoarseness of voice	For the all patients, the incidence of postoperative hoarseness of the voice in 6 hours follow-up period based on the different types of medications were obtained (using questionnaire).	6 hours after surgery	Yes
Primary	hoarseness of voice	For the all patients, the incidence of postoperative hoarseness of the voice in 24 hours follow-up period based on the different types of medications were obtained (using questionnaire).	24 hours after surgery	Yes