Muscle RelaxantsPhase 4NCT02467595
The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy
A Phase 4 study testing Rocuronium bromide 0.15 mg kg-1, Rocuronium bromide 0.3 mg kg-1 and Fentanyl in people with Muscle Relaxants, run by Korea University Anam Hospital.
Trial summary
This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Relaxants
- What is being tested?
- Rocuronium bromide 0.15 mg kg-1, Rocuronium bromide 0.3 mg kg-1 and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2016
- Phase
- Phase 4
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiologist[ASA] class 1-2
- scheduled adenotonsillectomy
- written informed consent
Who cannot join
- allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
- known or suspected upper respiratory infection
- disorder affecting neuromuscular blockade
- suspected difficult tracheal intubation
- Developmental Disability
- known or suspected psychologic disorder
- medication (psychoactive drugs)
About this study
Official title: The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy
This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.
Read the detailed description
Adenotonsillectomy in children is a short surgical procedure under general anesthesia. The ideal muscle relaxant requires intense neuromuscular block for optimal surgical work and complete recovery of neuromuscular function immediately after the end of the surgical procedure without postoperative morbidity. Rocuronium is an intermediate acting neuromuscular blockade. Reduced-dose rocuronium has been reported to provide optimal anesthetic induction without delayed recovery. The investigators aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.
After Institutional Review Board approval and written informed consent from the parents were obtained, 75 children (aged 3 to 10 years, ASA(The American Society of Anesthesia ) I or II) scheduled for adenotonsillectomy were included. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium 0.15 mg kg-1 (R 0.15 group) or rocuronium 0.3mg kg-1 (R 0.3 group) or saline (S group). After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. The investigators assessed conditions during tracheal intubation as excellent, good or poor, using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs. The investigators added rocuronium 0.3 mg kg-1 when there was more than one poor condition. The investigators recorded the time from discontinuation of sevoflurane to time to extubation.
- Conditions
- Muscle Relaxants
- Being tested
- Rocuronium bromide 0.15 mg kg-1, Rocuronium bromide 0.3 mg kg-1, Fentanyl, Propofol, Sevoflurane
- Keywords
- no muscle relaxant, rocuronium, intubation condition, tracheal intubation, operating room time, low-dose rocuronium
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium bromide 0.15 mg kg-1Drug
Also called Esmerone
Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.
Rocuronium bromide 0.3 mg kg-1Drug
Also called Esmerone
Rocuronium 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.
FentanylDrug
Also called 하나구연산펜타닐주사
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
PropofolDrug
Also called Fresofol MCT 1%
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
SevofluraneDrug
Also called 세보프란 흡입액
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
| Study group | Role | What they receive |
|---|---|---|
| R 0.15 group | Experimental | Rocuronium bromide 0.15 mg kg-1 group
1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.15 mg kg-1
2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room.
4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 .
Drug: Rocuronium bromide Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy. Receives: Drug: Rocuronium bromide 0.15 mg kg-1; Drug: Fentanyl; Drug: Propofol; Drug: Sevoflurane |
| R 0.3 group | Active comparator | Rocuronium bromide 0.3 mg kg-1 group
1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.3 mg kg-1
2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room.
4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 .
Drug: Rocuronium bromide Rocuronium bromide 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy. Receives: Drug: Rocuronium bromide 0.3 mg kg-1; Drug: Fentanyl; Drug: Propofol; Drug: Sevoflurane |
| S group | Placebo comparator | saline
1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and saline.
2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room.
4. When poor intubating condition., added rocuronium bromide0.3 mg kg-1 . Receives: Drug: Fentanyl; Drug: Propofol; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditions during tracheal intubation
We assessed conditions during tracheal intubation as excellent, good or poor, and additionally using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.
Measured: At the time to tracheal intubation, after mask ventilation for 2 minutes
Secondary outcomes (1)
time to extubation
When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.
Measured: intraoperatve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Muscle RelaxantsStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangjae Park, Korea University Anam Hospital
- Investigators
- Jang Eun Cho, M.D.,Ph.D., Principal investigator, Anesthesia and pain medicine department, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467595
- Sponsor's protocol ID
- ED14142
- Status last verified
- Jan 2016
- First submitted
- 11 May 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Huh H, Park JJ, Kim JY, Kim TH, Yoon SZ, Shin HW, Lee HW, Lim HJ, Cho JE. Optimal dose of rocuronium bromide undergoing adenotonsillectomy under 5% sevoflurane with fentanyl. Int J Pediatr Otorhinolaryngol. 2017 Oct;101:70-74. doi: 10.1016/j.ijporl.2017.07.030. Epub 2017 Jul 25.
PubMed 28964314
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT02467595
- Acronym / sponsor ID
- ED14142
- Conditions
- Muscle Relaxants
- Keywords
- no muscle relaxant, rocuronium, intubation condition, tracheal intubation, operating room time, low-dose rocuronium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- 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 aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.
Detailed description
Adenotonsillectomy in children is a short surgical procedure under general anesthesia. The ideal muscle relaxant requires intense neuromuscular block for optimal surgical work and complete recovery of neuromuscular function immediately after the end of the surgical procedure without postoperative morbidity. Rocuronium is an intermediate acting neuromuscular blockade. Reduced-dose rocuronium has been reported to provide optimal anesthetic induction without delayed recovery. The investigators aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.
After Institutional Review Board approval and written informed consent from the parents were obtained, 75 children (aged 3 to 10 years, ASA(The American Society of Anesthesia ) I or II) scheduled for adenotonsillectomy were included. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium 0.15 mg kg-1 (R 0.15 group) or rocuronium 0.3mg kg-1 (R 0.3 group) or saline (S group). After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. The investigators assessed conditions during tracheal intubation as excellent, good or poor, using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs. The investigators added rocuronium 0.3 mg kg-1 when there was more than one poor condition. The investigators recorded the time from discontinuation of sevoflurane to time to extubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R 0.15 group | Experimental | Drug: Rocuronium bromide 0.15 mg kg-1, Drug: Fentanyl, Drug: Propofol, Drug: SevofluraneRocuronium bromide 0.15 mg kg-1 group 1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.15 mg kg-1 2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. 3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy. |
| R 0.3 group | Active comparator | Drug: Rocuronium bromide 0.3 mg kg-1, Drug: Fentanyl, Drug: Propofol, Drug: SevofluraneRocuronium bromide 0.3 mg kg-1 group 1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.3 mg kg-1 2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. 3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy. |
| S group | Placebo comparator | Drug: Fentanyl, Drug: Propofol, Drug: Sevofluranesaline 1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and saline. 2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. 3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 4. When poor intubating condition., added rocuronium bromide0.3 mg kg-1 . |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist[ASA] class 1-2
- scheduled adenotonsillectomy
- written informed consent
Key exclusion criteria (7 listed)
- allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
- known or suspected upper respiratory infection
- disorder affecting neuromuscular blockade
- suspected difficult tracheal intubation
- Developmental Disability
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 bromide 0.15 mg kg-1Also: EsmeroneRocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy. | Drug | R 0.15 group |
| Rocuronium bromide 0.3 mg kg-1Also: EsmeroneRocuronium 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy. | Drug | R 0.3 group |
| FentanylAlso: 하나구연산펜타닐주사Fentanyl 2 mcg kg-1 was injected at I.V. line to patients | Drug | R 0.15 group, R 0.3 group, S group |
| PropofolAlso: Fresofol MCT 1%Propofol 2.5 mg kg-1 was injected at I.V. line to patients | Drug | R 0.15 group, R 0.3 group, S group |
| SevofluraneAlso: 세보프란 흡입액After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. | Drug | R 0.15 group, R 0.3 group, S group |
Primary outcome
Conditions during tracheal intubation
Time frame: At the time to tracheal intubation, after mask ventilation for 2 minutes
We assessed conditions during tracheal intubation as excellent, good or poor, and additionally using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.
1 secondary outcome
time to extubation
Time frame: intraoperatve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 28964314Huh H, Park JJ, Kim JY, Kim TH, Yoon SZ, Shin HW, Lee HW, Lim HJ, Cho JE. Optimal dose of rocuronium bromide undergoing adenotonsillectomy under 5% sevoflurane with fentanyl. Int J Pediatr Otorhinolaryngol. 2017 Oct;101:70-74. doi: 10.1016/j.ijporl.2017.07.030. Epub 2017 Jul 25.
- Individual participant dataSharing planned: No
Related trials for Muscle Relaxants
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Recruiting
Small Doses Muscle Relaxant in General Anesthesia
Muscle Relaxant
Recruiting
Impact of Entropy Monitoring on Anesthetic Consumption and Recovery After Laparoscopic Cholecystectomy
Entropy Device and How Will Muscle Relaxants Affect it
RecruitingObservational study
Effect of Muscle Relaxants on Postoperative Sore Throat in Video Laryngeal Mask Airway(LMA) Use
Laryngeal Mask Airway
Enrolling by invitationPhase 3
Efficacy and Safety of HRS-9190 in General Anesthesia
Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective Surgery
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.
Jang Eun Cho, M.D.,Ph.D. principal investigator
Anesthesia and pain medicine department, Korea University Anam Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium bromide 0.15 mg kg-1, Rocuronium bromide 0.3 mg kg-1 and Fentanyl in people with Muscle Relaxants, run by Korea University Anam Hospital.
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 3 inclusion and 7 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 27 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Conditions during tracheal intubation (time frame: At the time to tracheal intubation, after mask ventilation for 2 minutes). 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 NCT02467595, 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 27 Jan 2016.