- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03259672
Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
August 21, 2017 updated by: Hyun-Chang Kim, Keimyung University Dongsan Medical Center
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
Exclusion Criteria:
- Difficult airway
- Friable teeth
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
- Asthma
- Chronic obstructive pulmonary disease
- Chronic cough
- Arrhythmia
- Coronary disease
- Heart failure
- Pregnancy
- Allergy to sevoflurane
- Allergy to desflurane
- Fever after halogenated anesthetics
- Jaundice after halogenated anesthetics
- Malignant hyperthremia
- Allergy to remifentanil
- Friable teeth
- History of head and neck surgery
- Multiple intubation attempts
- Regional anesthetic agents
- Gastric tube
- Dexamethasone
- Severe hypovolemia
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: Sevoflurane
|
Sevoflurane was used as a maintenance anesthetic agent.
|
Experimental: Desflurane
|
Desflurane was used as a maintenance anesthetic agent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with postoperative sore throat
Time Frame: At 24 hr
|
At 24 hr
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with additional pain medication
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Visual analogue scale of postoperative pain
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Number of participants with shivering
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Requirements of analgesics
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Number of participants with postoperative sore throat
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Number of participants with postoperative hoarseness
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Number of participants with postoperative cough
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Number of participants with postoperative nausea
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Number of participants with postoperative vomiting
Time Frame: At 0, 2, 4 and 24 hr
|
At 0, 2, 4 and 24 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
October 1, 2017
Primary Completion (Anticipated)
October 1, 2018
Study Completion (Anticipated)
November 1, 2018
Study Registration Dates
First Submitted
August 21, 2017
First Submitted That Met QC Criteria
August 21, 2017
First Posted (Actual)
August 24, 2017
Study Record Updates
Last Update Posted (Actual)
August 24, 2017
Last Update Submitted That Met QC Criteria
August 21, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Pharyngitis
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Desflurane
- Sevoflurane
Other Study ID Numbers
- SevoDesPOST
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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