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NCT02252419 Clinical Trial

Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

Pharyngitis Clinical Trial

Official title:
Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02252419
Other study ID # SoreThroatParacetamol
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 26, 2014
Last updated October 16, 2014
Start date October 2014
Est. completion date March 2015

Study information
Verified date September 2014
Source Seoul National University Hospital
Contact Hyun-Chang Kim, MD
Phone 82-10-2886-2876
Email onidori1979@gmail.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Description:

The postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. Dexamethasone is known to effective for the prevention of postoperative sore throat. The combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated.

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 242
Est. completion date March 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients scheduled for urologic surgery under general anesthesia

- ASA I-III

Exclusion Criteria:

- Patients with recent sore throat

- Patients with neck surgery

- Patients with anticipated difficult airway

- Patients with Mallampati grade 3

- Patients with severe cardiovascular or pulmonary disease

- Patients with allergic history to dexamethasone or paracetamol

- Patients with liver function disorder

- Patients with liver disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
Dexamethasone will be administered.
• Paracetamol
Paracetamol will be administered.

Locations
Country Name City State
Korea, Republic of Seolu National University of Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative sore throat Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe) 1 hour postoperatively No
Secondary Postoperative sore throat degree Postoperative sore throat degree after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable). 0, 1, 6, 24 hour postoperatively No
Secondary Postoperative pain Postoperative pain after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable). 0, 1, 6, 24 hour postoperatively No
Secondary Nausea Nausea will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Vomiting Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Somnolence Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Shivering Shivering will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Headache Headache will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Hoarseness Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Dysphagia Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Analgesics Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6, 24 hour postoperatively No
Secondary Postoperative sore throat Postoperative sore throat after 0, 6, 24 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe) 0, 6, 24 hour postoperatively No
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