Hip ArthroplastyNCT03259672
Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
A study testing Sevoflurane and Desflurane in people with Hip Arthroplasty, run by Keimyung University Dongsan Medical Center.
Trial summary
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Arthroplasty
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
Who cannot join
- Difficult airway
- Friable teeth
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
- Asthma
Show all 25Show fewer
- 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
About this study
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.
- Conditions
- Hip Arthroplasty
- Being tested
- Sevoflurane, Desflurane
- Keywords
- intubation, pharyngitis, remifentanil
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane was used as a maintenance anesthetic agent.
DesfluraneDrug
Desflurane was used as a maintenance anesthetic agent.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Not described Receives: Drug: Sevoflurane |
| Desflurane | Experimental | Not described Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative sore throat
Measured: At 24 hr
Secondary outcomes (9)
Number of participants with postoperative sore throat
Measured: At 0, 2, 4 and 24 hr
Number of participants with postoperative hoarseness
Measured: At 0, 2, 4 and 24 hr
Number of participants with postoperative cough
Measured: At 0, 2, 4 and 24 hr
Number of participants with postoperative nausea
Measured: At 0, 2, 4 and 24 hr
Number of participants with postoperative vomiting
Measured: At 0, 2, 4 and 24 hr
Number of participants with additional pain medication
Measured: At 0, 2, 4 and 24 hr
Visual analogue scale of postoperative pain
Measured: At 0, 2, 4 and 24 hr
Number of participants with shivering
Measured: At 0, 2, 4 and 24 hr
Requirements of analgesics
Measured: At 0, 2, 4 and 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Chang Kim, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259672
- Sponsor's protocol ID
- SevoDesPOST
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT03259672
- Acronym / sponsor ID
- SevoDesPOST
- Conditions
- Hip Arthroplasty
- Keywords
- intubation, pharyngitis, remifentanil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: Sevoflurane |
| Desflurane | Experimental | Drug: Desflurane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
Key exclusion criteria (25 listed)
- Difficult airway
- Friable teeth
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneSevoflurane was used as a maintenance anesthetic agent. | Drug | Sevoflurane |
| DesfluraneDesflurane was used as a maintenance anesthetic agent. | Drug | Desflurane |
Primary outcome
Number of participants with postoperative sore throat
Time frame: At 24 hr
9 secondary outcomes
Number of participants with postoperative sore throat
Time frame: At 0, 2, 4 and 24 hr
Number of participants with postoperative hoarseness
Time frame: At 0, 2, 4 and 24 hr
Number of participants with postoperative cough
Time frame: At 0, 2, 4 and 24 hr
Number of participants with postoperative nausea
Time frame: At 0, 2, 4 and 24 hr
Number of participants with postoperative vomiting
Time frame: At 0, 2, 4 and 24 hr
Number of participants with additional pain medication
Time frame: At 0, 2, 4 and 24 hr
Visual analogue scale of postoperative pain
Time frame: At 0, 2, 4 and 24 hr
Number of participants with shivering
Time frame: At 0, 2, 4 and 24 hr
Requirements of analgesics
Time frame: At 0, 2, 4 and 24 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Desflurane in people with Hip Arthroplasty, run by Keimyung University Dongsan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative sore throat (time frame: At 24 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.