Influence of Sevoflurane and Desflurane on Postoperative... | NCT03259672

Studies
Influence of Sevoflurane and Desflurane on Postoperative Sore Throat

NCT03259672

Sponsor

Keimyung University Dongsan Medical Center

Status

Unknown status

Last Update Posted

Aug 24, 2017Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Hip Arthroplasty

Interventions

Sevoflurane
Desflurane

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Estimated

Primary Completion Date

Oct 1, 2018Estimated

Completion Date

Nov 1, 2018Estimated

First Submitted Date

Aug 21, 2017

First Submission Date that Met QC Criteria

Aug 21, 2017

First Posted Date

Aug 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2017

Last Update Posted Date

Aug 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyun-Chang Kim, Assistant professor, Keimyung University Dongsan Medical CenterPrincipal Investigator

Lead Sponsor

Keimyung University Dongsan Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Active Comparator		Drug: Sevoflurane
Desflurane	Experimental		Drug: Desflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	Sevoflurane was used as a maintenance anesthetic agent.	Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with postoperative sore throat		At 24 hr

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with postoperative sore throat		At 0, 2, 4 and 24 hr
Number of participants with postoperative hoarseness		At 0, 2, 4 and 24 hr
Number of participants with postoperative cough

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010612	Pharyngitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D000077335	Desflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided