Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252419
Recruitment Status : Unknown
Verified September 2014 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 30, 2014
Last Update Posted : October 17, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pharyngitis Drug: Dexamethasone Drug: Paracetamol Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery
Study Start Date : October 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Nausea [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.

  4. Vomiting [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.

  5. Somnolence [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively.

  6. Shivering [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Shivering will be measured at 0, 1, 6 and 24 hour postoperatively.

  7. Headache [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Headache will be measured at 0, 1, 6 and 24 hour postoperatively.

  8. Hoarseness [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively.

  9. Dysphagia [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively.

  10. Analgesics [ Time Frame: 0, 1, 6, 24 hour postoperatively ]
    Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively.

  11. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252419


Contacts
Layout table for location contacts
Contact: Hyun-Chang Kim, MD 82-10-2886-2876 onidori1979@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seolu National University of Hospital
Seoul, Korea, Republic of
Contact: Hyun-Chang Kim, MD    83-10-2886-2876    onidori1979@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hee-Pyoung Park, PhD Seoul National University of Hospital

Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02252419    
Other Study ID Numbers: SoreThroatParacetamol
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: September 2014
Keywords provided by Seoul National University Hospital:
Postoperative Period
Anesthesia, General
Intubation, Intratracheal
Dexamethasone
Acetaminophen
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Acetaminophen
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antipyretics