Hip ArthroplastyNCT03173339
Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
A study testing Endotracheal intubation using laryngoscope, High remifentanil and Low remifentanil in people with Hip Arthroplasty, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil. 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?
- Endotracheal intubation using laryngoscope, High remifentanil and Low remifentanil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 24 Aug 2017
- 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
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
- Asthma
- Chronic obstructive pulmonary disease
Show all 15Show fewer
- Chronic cough
- Pregnancy
- Allergy to remifentanil
- Friable teeth
- History of head and neck surgery
- Multiple intubation attempts
- Regional anesthetic agents
- Gastric tube
- Dexamethasone
Trial locations and contacts
1 site in 1 country.
About this study
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.
- Conditions
- Hip Arthroplasty
- Being tested
- Endotracheal intubation using laryngoscope, High remifentanil, Low remifentanil, High sevoflurane, Low sevoflurane
- 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.
Endotracheal intubation using laryngoscopeProcedure or surgery
Endotracheal intubation was done using laryngoscope for general anesthesia.
High remifentanilDrug
Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.
Low remifentanilDrug
Remifentanil was administered as 0.1 mcg/kg/min.
High sevofluraneDrug
Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.
Low sevofluraneDrug
Sevoflurane was administered as 0.5 MAC.
| Study group | Role | What they receive |
|---|---|---|
| Low remifentanil and high sevoflurane | Active comparator | Remifentanil was administered as 0.1 mcg/kg/min. Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %. Receives: Procedure: Endotracheal intubation using laryngoscope; Drug: Low remifentanil; Drug: High sevoflurane |
| High remifentanil and low sevoflurane | Experimental | Sevoflurane was administered as 0.5 MAC. Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min. Receives: Procedure: Endotracheal intubation using laryngoscope; Drug: High remifentanil; Drug: Low sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with sore throat
Measured: At 24 hr
Secondary outcomes (9)
Number of participants with sore throat
Measured: At 0, 2, 4 and 24 hr
Number of participants with hoarseness
Measured: At 0, 2, 4 and 24 hr
Number of participants with cough
Measured: At 0, 2, 4 and 24 hr
Number of participants with nausea
Measured: At 0, 2, 4 and 24 hr
Number of participants with 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 posted1 Jun 2017
- Study start1 Jun 2017
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyun-Chang Kim, MD. Ph. D., Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173339
- Sponsor's protocol ID
- HighRemiSoreThroat
- Status last verified
- May 2017
- First submitted
- 29 May 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park JH, Lee YC, Lee J, Kim H, Kim HC. The influence of high-dose intraoperative remifentanil on postoperative sore throat: a prospective randomized study: A CONSORT compliant article. Medicine (Baltimore). 2018 Dec;97(50):e13510. doi: 10.1097/MD.0000000000013510.
PubMed 30558006
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03173339
- Acronym / sponsor ID
- HighRemiSoreThroat
- Conditions
- Hip Arthroplasty
- Keywords
- intubation, pharyngitis, remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 1 Jun 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 dose of remifentanil.
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 |
|---|---|---|
| Low remifentanil and high sevoflurane | Active comparator | Procedure: Endotracheal intubation using laryngoscope, Drug: Low remifentanil, Drug: High sevofluraneRemifentanil was administered as 0.1 mcg/kg/min. Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %. |
| High remifentanil and low sevoflurane | Experimental | Procedure: Endotracheal intubation using laryngoscope, Drug: High remifentanil, Drug: Low sevofluraneSevoflurane was administered as 0.5 MAC. Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min. |
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 (15 listed)
- Difficult airway
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
- Asthma
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 |
|---|---|---|
| Endotracheal intubation using laryngoscopeEndotracheal intubation was done using laryngoscope for general anesthesia. | Procedure or surgery | High remifentanil and low sevoflurane, Low remifentanil and high sevoflurane |
| High remifentanilRemifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min. | Drug | High remifentanil and low sevoflurane |
| Low remifentanilRemifentanil was administered as 0.1 mcg/kg/min. | Drug | Low remifentanil and high sevoflurane |
| High sevofluraneSevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %. | Drug | Low remifentanil and high sevoflurane |
| Low sevofluraneSevoflurane was administered as 0.5 MAC. | Drug | High remifentanil and low sevoflurane |
Primary outcome
Number of participants with sore throat
Time frame: At 24 hr
9 secondary outcomes
Number of participants with sore throat
Time frame: At 0, 2, 4 and 24 hr
Number of participants with hoarseness
Time frame: At 0, 2, 4 and 24 hr
Number of participants with cough
Time frame: At 0, 2, 4 and 24 hr
Number of participants with nausea
Time frame: At 0, 2, 4 and 24 hr
Number of participants with 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Derived from this study: PubMed 30558006Park JH, Lee YC, Lee J, Kim H, Kim HC. The influence of high-dose intraoperative remifentanil on postoperative sore throat: a prospective randomized study: A CONSORT compliant article. Medicine (Baltimore). 2018 Dec;97(50):e13510. doi: 10.1097/MD.0000000000013510.
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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.
Hyun-Chang Kim, MD. Ph. D. principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation using laryngoscope, High remifentanil and Low remifentanil in people with Hip Arthroplasty, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 15 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: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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?
On the ClinicalTrials.gov record for NCT03173339, which also lists 1 linked publication.
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 25 Aug 2017.