Post Operative Sore ThroatNCT05345574
A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
A study testing dexmedetomidine infusion and remifentanil infusion in people with Post Operative Sore Throat, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post Operative Sore Throat
- What is being tested?
- dexmedetomidine infusion and remifentanil infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Dec 2018to 31 Dec 2022
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification I and II
- Undergoing lumbar spine surgery in prone position
Who cannot join
- Pre-existing sore throat, hoarseness, or upper respiratory tract infection
- Allergy to the study drugs
- Anticipated difficult airways
- More than two attempts at intubation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Eun kyung Choi
Daegu, Korea (the Republic Of), 42415
Eun kyung Choi, MD,phD, +82-53-620-3361, zzini0527@naver.com
About this study
Official title: The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.
- Conditions
- Post Operative Sore Throat
- Being tested
- dexmedetomidine infusion, remifentanil infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine infusionDrug
dexmedetomidine as anaesthetic adjuvant
remifentanil infusionDrug
remifentanil as anaesthetic adjuvant
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine infusion group | Active comparator | dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery Receives: Drug: dexmedetomidine infusion |
| remifentanil infusion group | Active comparator | remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery Receives: Drug: remifentanil infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative sore throat at rest
0=none; 1=occur
Measured: 1 hour after surgery
incidence of postoperative sore throat at swallowing
0=none; 1=occur
Measured: 1 hour after surgery
severity of postoperative sore throat at rest
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: 1 hour after surgery
severity of postoperative sore throat at swallowing
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start26 Dec 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Sore ThroatStudies 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Kyung Choi, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345574
- Sponsor's protocol ID
- YUMC 2018-09-029
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
- ClinicalTrials.gov ID
- NCT05345574
- Acronym / sponsor ID
- YUMC 2018-09-029
- Conditions
- Post Operative Sore Throat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Apr 2022 (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 study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.
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 |
|---|---|---|
| dexmedetomidine infusion group | Active comparator | Drug: dexmedetomidine infusiondexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery |
| remifentanil infusion group | Active comparator | Drug: remifentanil infusionremifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status classification I and II
- Undergoing lumbar spine surgery in prone position
Key exclusion criteria (4 listed)
- Pre-existing sore throat, hoarseness, or upper respiratory tract infection
- Allergy to the study drugs
- Anticipated difficult airways
- More than two attempts at intubation
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 |
|---|---|---|
| dexmedetomidine infusiondexmedetomidine as anaesthetic adjuvant | Drug | dexmedetomidine infusion group |
| remifentanil infusionremifentanil as anaesthetic adjuvant | Drug | remifentanil infusion group |
Primary outcome
incidence of postoperative sore throat at rest
Time frame: 1 hour after surgery
0=none; 1=occur
incidence of postoperative sore throat at swallowing
Time frame: 1 hour after surgery
0=none; 1=occur
severity of postoperative sore throat at rest
Time frame: 1 hour after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
severity of postoperative sore throat at swallowing
Time frame: 1 hour after surgery
4-point scale (0=none; 1=mild; 2=moderate; 3=severe)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine infusion and remifentanil infusion in people with Post Operative Sore Throat, run by Yeungnam University College of Medicine 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 4 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 26 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative sore throat at rest (time frame: 1 hour after surgery). The study lists 4 primary outcomes in all. 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 26 Apr 2022.