Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

Not Applicable

• Conditions: Pharyngitis
• Interventions: Drug: Dexamethasone; Drug: Paracetamol

• Registration Number: NCT02252419
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-09-30
• Study Start: 2014-10
• Last Update Submitted: 2014-10-16
• Last Update Posted: 2014-10-17
• Primary Completion: 2015-02
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone+ Paracetamol (DP)	Paracetamol	Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.
Dexamethasone	Dexamethasone	Dexamethasone will be administered 30 minutes before the anesthetic induction.
Dexamethasone+ Paracetamol (DP)	Dexamethasone	Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.

Primary Outcome Measures

Name	Time	Method
Postoperative sore throat	1 hour postoperatively	Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	0, 1, 6, 24 hour postoperatively	Postoperative pain after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).
Vomiting	0, 1, 6, 24 hour postoperatively	Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Postoperative sore throat degree	0, 1, 6, 24 hour postoperatively	Postoperative sore throat degree after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).
Nausea	0, 1, 6, 24 hour postoperatively	Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Somnolence	0, 1, 6, 24 hour postoperatively	Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively.
Headache	0, 1, 6, 24 hour postoperatively	Headache will be measured at 0, 1, 6 and 24 hour postoperatively.
Hoarseness	0, 1, 6, 24 hour postoperatively	Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively.
Dysphagia	0, 1, 6, 24 hour postoperatively	Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively.
Postoperative sore throat	0, 6, 24 hour postoperatively	Postoperative sore throat after 0, 6, 24 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)
Shivering	0, 1, 6, 24 hour postoperatively	Shivering will be measured at 0, 1, 6 and 24 hour postoperatively.
Analgesics	0, 1, 6, 24 hour postoperatively	Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively.

Trial Locations

Locations (1)

Seolu National University of Hospital; 🇰🇷 Seoul, Korea, Republic of