Back to results

Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

Primary Purpose

Pharyngitis

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Dexamethasone

Paracetamol

About this trial

This is an interventional prevention trial for Pharyngitis focused on measuring Postoperative Period, Anesthesia, General, Intubation, Intratracheal, Dexamethasone, Acetaminophen

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seolu National University of Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dexamethasone

Dexamethasone+ Paracetamol (DP)

Arm Description

Dexamethasone will be administered 30 minutes before the anesthetic induction.

Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.

Outcomes

Primary Outcome Measures

Postoperative sore throat

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

Secondary Outcome Measures

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).

Postoperative pain

Postoperative pain after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).

Nausea

Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.

Vomiting

Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.

Somnolence

Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively.

Shivering

Shivering will be measured at 0, 1, 6 and 24 hour postoperatively.

Headache

Headache will be measured at 0, 1, 6 and 24 hour postoperatively.

Hoarseness

Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively.

Dysphagia

Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively.

Analgesics

Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively.

Postoperative sore throat

Postoperative sore throat after 0, 6, 24 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)

Full Information

NCT ID

NCT02252419

First Posted

September 26, 2014

Last Updated

October 16, 2014

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02252419

Brief Title

Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngitis

Keywords

Postoperative Period, Anesthesia, General, Intubation, Intratracheal, Dexamethasone, Acetaminophen

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

Dexamethasone will be administered 30 minutes before the anesthetic induction.

Arm Title

Dexamethasone+ Paracetamol (DP)

Arm Type

Experimental

Arm Description

Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone will be administered.

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

Paracetamol will be administered.

Primary Outcome Measure Information:

Title

Postoperative sore throat

Description

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

Time Frame

1 hour postoperatively

Secondary Outcome Measure Information:

Title

Postoperative sore throat degree

Description

Postoperative sore throat degree after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable).

Time Frame