Sore ThroatNCT03391700
Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
A study testing Rocuronium(deep) and Rocuronium(moderate) in people with 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 maintaining moderate relaxation and deep relaxation during 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(deep) and Rocuronium(moderate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 14 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirement for mechanical ventilation under general anesthesia
Who cannot join
- Hoarseness and sore throat existed before surgery
- Upper respiratory infection
- Known or predicted difficult airway
- Liver, renal disease
- Requirement of postoperative ventilator care
- the operation within 2hrs
- Laparoscopic surgery
- Other positions except supine during surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jee-Eun Chang
Seoul, 07061
Jee-Eun Chang, M.D., +82-2-870-2517, sw411528@hanmail.net
About this study
Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.
Read the detailed description
In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.
- Conditions
- Sore Throat
- Being tested
- Rocuronium(deep), Rocuronium(moderate)
- 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.
Rocuronium(deep)Drug
In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).
Rocuronium(moderate)Drug
In the group with deep relaxation during surgery, rocuronium is given by bolus dose(0.15mg/kg) induced a train of four count of 1-2.
| Study group | Role | What they receive |
|---|---|---|
| Moderate muscle relaxation | Active comparator | Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute. Receives: Drug: Rocuronium(moderate) |
| Deep muscle relaxation | Experimental | Rocuronium is administered to maintain deep relaxation during operation. Receives: Drug: Rocuronium(deep) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of postoperative sore throat
The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period
Measured: Within 24 hrs after operation
Secondary outcomes (4)
The incidence of postoperative sore throat
The presence of sore throat is assessed.
Measured: At 1,6, and 24 hrs after operation
The severity of postoperative sore throat
The severity of sore throat is assessed by using a 100-point numerical ratig scale (NRS, 0 [no pain], 100 [worst pain imaginable]).
Measured: At 1,6, and 24 hrs 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 hrs after operation
Postoperative analgesic consumption
The amount of patient-controlled analgesia and other analgesic medication used
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 posted5 Jan 2018
- Study start1 Aug 2017
- Primary completion14 Jul 2018 (estimated)
- Study completion14 Aug 2019 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 206 participants (estimated)
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
- Jee-eun Chang, M.D, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391700
- Sponsor's protocol ID
- 20170601/10-2017-4/071
- Status last verified
- Jun 2018
- First submitted
- 9 Nov 2017
- Last updated
- 26 Jun 2018
- 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 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
- ClinicalTrials.gov ID
- NCT03391700
- Acronym / sponsor ID
- 20170601/10-2017-4/071
- Conditions
- Sore Throat
- Keywords
- muscle relaxant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 14 Jul 2018 (estimated)
- Study completion
- 14 Aug 2019 (estimated)
- First posted
- 5 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 maintaining moderate relaxation and deep relaxation during operation.
Detailed description
In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate muscle relaxation | Active comparator | Drug: Rocuronium(moderate)Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute. |
| Deep muscle relaxation | Experimental | Drug: Rocuronium(deep)Rocuronium is administered to maintain deep relaxation during operation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Requirement for mechanical ventilation under general anesthesia
Key exclusion criteria (8 listed)
- Hoarseness and sore throat existed before surgery
- Upper respiratory infection
- Known or predicted difficult airway
- Liver, renal disease
- Requirement of postoperative ventilator care
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 |
|---|---|---|
| Rocuronium(deep)In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h). | Drug | Deep muscle relaxation |
| Rocuronium(moderate)In the group with deep relaxation during surgery, rocuronium is given by bolus dose(0.15mg/kg) induced a train of four count of 1-2. | Drug | Moderate muscle relaxation |
Primary outcome
Overall incidence of postoperative sore throat
Time frame: Within 24 hrs after operation
The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period
4 secondary outcomes
The incidence of postoperative sore throat
Time frame: At 1,6, and 24 hrs after operation
The severity of postoperative sore throat
Time frame: At 1,6, and 24 hrs after operation
Incidence and severity of postoperative hoarseness
Time frame: At 1,6, and 24 hrs after operation
Postoperative analgesic consumption
Time frame: Within 24 hrs after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- 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.
Jee-eun Chang, M.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?
A study testing Rocuronium(deep) and Rocuronium(moderate) in people with 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 1 inclusion and 8 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 Jun 2018. 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?
Contact Jee-Eun Chang, M.D (82-2-870-2517, sw411528@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of postoperative sore throat (time frame: Within 24 hrs after operation). 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 Jun 2018.