Sore ThroatNCT03397797
Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness
An observational study of Sore Throat, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Investigators assess and compare postoperative sore throat and hoarseness in the group using the muscle relaxant and not using it during the operation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sore Throat
- What is being tested?
- Rocuronium
- How many people
- 117 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2017to 29 Nov 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective lumbar spinal surgery
Who may be able to join
- patients scheduled to undergo elective lumbar spinal surgery Exclusion criteria
- known or predicted difficult airway
- neuromuscular diseases
- hepatic or renal dysfunction
- diseases or anatomical abnormalities in the neck, larynx, or pharynx
- requirement for postoperative mechanical ventilation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness in Patients Undergoing Spinal Surgery
Investigators assess and compare postoperative sore throat and hoarseness in the group using the muscle relaxant and not using it during the operation.
Read the detailed description
The muscle relaxant is usually used during the operation to maintain moderate relaxation but, it can't be used in the surgery to need eletrophysiological monitoring during the operation. In this sturdy, the investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxant in the group using the muscle relaxant and not using it in terms of the incidence and severity of postoperative sore throat and hoarseness.
- Conditions
- Sore Throat
- Being tested
- Rocuronium
- Keywords
- muscle relaxant
- Medical subject headings
- Pharyngitis, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
In the group to need the eletrophysiological monitoring during the operation, we don't inject muscle relaxant except anestheitic induction.
| Study group | Role | What they receive |
|---|---|---|
| Group with muscle relaxant | Rocuronium is used during the operation to maintain moderate relaxation. Receives: Drug: Rocuronium | |
| Group without muscle relaxant | Rocuronium is not used during the operation for the eletrophysiological monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cumulative incidence of postoperative sore throat
The incidence sore throat is assessed by the presence of sore throat
Measured: Within 24 hr evaluation period after operation
Overall cumulative incidence of postoperative hoarseness
The incidence sore throat is assessed by the degree of hoarseness
Measured: Within 24 hr evaluation period after operation
Secondary outcomes (4)
Incidence of postoperative sore throat
The incidence of sore throat is assessed by the presence of sore throat.
Measured: At 1,6, and 24 hr after operation
Severity of postoperative sore throat
A 0-100 mm NRS is used to evaluate the severity of sore throat (0, no pain; 100, worst pain imaginable).
Measured: At 1,6, and 24 hr after operation
Incidence and severity of postoperative hoarseness
Hoarseness is defined as a voice quality different from the preoperative voice and graded as follows: none (no hoarseness), mild (recognized by the patient), moderate (obvious to the investigator), and severe (aphonia).
Measured: At 1,6, and 24 hr after operation
Post operative analgesic consumption
the amount of patient-controlled analgesia and other analgesic medication consumed
Measured: within 24 hrs after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Sep 2017
- Primary completion28 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Yong Hwang, M.D.,Ph. D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397797
- Sponsor's protocol ID
- 20170605/10-2017-6/063
- Status last verified
- Dec 2019
- First submitted
- 9 Nov 2017
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness in Patients Undergoing Spinal Surgery
- ClinicalTrials.gov ID
- NCT03397797
- Acronym / sponsor ID
- 20170605/10-2017-6/063
- Conditions
- Sore Throat
- Keywords
- muscle relaxant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 12 Jan 2018 (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.
Investigators assess and compare postoperative sore throat and hoarseness in the group using the muscle relaxant and not using it during the operation.
Detailed description
The muscle relaxant is usually used during the operation to maintain moderate relaxation but, it can't be used in the surgery to need eletrophysiological monitoring during the operation. In this sturdy, the investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxant in the group using the muscle relaxant and not using it in terms of the incidence and severity of postoperative sore throat and hoarseness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with muscle relaxant | – | Drug: RocuroniumRocuronium is used during the operation to maintain moderate relaxation. |
| Group without muscle relaxant | – | –Rocuronium is not used during the operation for the eletrophysiological monitoring. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective lumbar spinal surgery
Key inclusion criteria (6 listed)
- patients scheduled to undergo elective lumbar spinal surgery Exclusion criteria
- known or predicted difficult airway
- neuromuscular diseases
- hepatic or renal dysfunction
- diseases or anatomical abnormalities in the neck, larynx, or pharynx
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RocuroniumIn the group to need the eletrophysiological monitoring during the operation, we don't inject muscle relaxant except anestheitic induction. | Drug | Group with muscle relaxant |
Primary outcome
Overall cumulative incidence of postoperative sore throat
Time frame: Within 24 hr evaluation period after operation
The incidence sore throat is assessed by the presence of sore throat
Overall cumulative incidence of postoperative hoarseness
Time frame: Within 24 hr evaluation period after operation
The incidence sore throat is assessed by the degree of hoarseness
4 secondary outcomes
Incidence of postoperative sore throat
Time frame: At 1,6, and 24 hr after operation
Severity of postoperative sore throat
Time frame: At 1,6, and 24 hr after operation
Incidence and severity of postoperative hoarseness
Time frame: At 1,6, and 24 hr after operation
Post operative analgesic consumption
Time frame: within 24 hrs after operation
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 20 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Jin-Yong Hwang, M.D.,Ph. D. principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sore Throat, run by SMG-SNU Boramae 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 6 inclusion and 0 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 20 Dec 2019. 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?
Overall cumulative incidence of postoperative sore throat (time frame: Within 24 hr evaluation period after operation). The study lists 2 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 20 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.