Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

October 16, 2014 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
Dexamethasone will be administered 30 minutes before the anesthetic induction.
Drug: Dexamethasone
Dexamethasone will be administered.
Experimental: Dexamethasone+ Paracetamol (DP)
Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Paracetamol
Paracetamol will be administered.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sore throat degree
Time Frame: 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).
0, 1, 6, 24 hour postoperatively
Postoperative pain
Time Frame: 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).
0, 1, 6, 24 hour postoperatively
Nausea
Time Frame: 0, 1, 6, 24 hour postoperatively
Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Vomiting
Time Frame: 0, 1, 6, 24 hour postoperatively
Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Somnolence
Time Frame: 0, 1, 6, 24 hour postoperatively
Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Shivering
Time Frame: 0, 1, 6, 24 hour postoperatively
Shivering will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Headache
Time Frame: 0, 1, 6, 24 hour postoperatively
Headache will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Hoarseness
Time Frame: 0, 1, 6, 24 hour postoperatively
Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Dysphagia
Time Frame: 0, 1, 6, 24 hour postoperatively
Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Analgesics
Time Frame: 0, 1, 6, 24 hour postoperatively
Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively.
0, 1, 6, 24 hour postoperatively
Postoperative sore throat
Time Frame: 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)
0, 6, 24 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee-Pyoung Park, PhD, Seoul National University of Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SoreThroatParacetamol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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