Neuromuscular BlockadeMISPCNUHHNCT02601508
Compare of Surgical Condition and Complications With Moderate and Deep NM Block
A study testing Rocuronium and cis-atracurium in people with Neuromuscular Blockade, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Rocuronium and cis-atracurium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.
Who cannot join
- Known allergy to rocuronuim, cisatracurium or sugammadex
- Significant liver or kidney dysfunction
- Any neuromuscular disease
- Pregnant or breast feeding
- Indication for rapid sequence induction
- Inability to give informed consent
- Patients taking any medication with potential interference with neuromuscular transmission
Trial locations and contacts
1 site in 1 country.
Shiyoung JEONG, MD contact
South Korea1 site
Chonnam University Hwasun Hospital
Hwasun, 519-763
Chanhong Park, BsC, +82-61-379-7598, cnuhpch@naver.com
Seongheon Lee, MD, PhD
About this study
Official title: A Randomized, Parallel Design, Single-center Study to Compare of Surgical Condition and Postoperative Complications With Moderate and Deep Neuromuscular Blockade in Laparoscopic Gastrectomy
This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.
Read the detailed description
Neuromuscular blocking agents (NMBAs) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. In an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (TOF) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. It has been called moderate neuromuscular blockade (mNMB) condition. Nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. If any hypothetical advantages of deep neuromuscular blockade (dNMB) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.
- Conditions
- Neuromuscular Blockade
- Being tested
- Rocuronium, cis-atracurium
- Keywords
- deep NM block, Surgeon's satisfaction, bridion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Esmeron®
Continuous infusion of rocuronium for PTC 1 + Sugammadex
cis-atracuriumDrug
Also called Nimbex®
Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine \& Glycopyrrolate
| Study group | Role | What they receive |
|---|---|---|
| Modarate Blockade Group | Active comparator | Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine \& glycopyrrolate will be given for the recovery. Receives: Drug: cis-atracurium |
| Deep Blockade Group | Experimental | Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical rating SCORE(SRS)
excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1)
Measured: every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery
Secondary outcomes (6)
Respiratory rate
Respiratory rate of patient
Measured: every 15 minutes from the arrival on the recovery room, up to 60 minutes
peripheral arterial oxygen saturation
peripheral arterial oxygen saturation(sPO2)
Measured: every 15 minutes from the arrival on the recovery room, up to 60 minutes
visual analogue scale (VAS) for pain
visual analogue scale (VAS) for pain
Measured: every 15 minutes from the arrival on the recovery room, up to 60 minutes
occurrence of nausea or vomiting
occurrence of nausea or vomiting with Rhodes Index
Measured: every 15 minutes from the arrival on the recovery room, up to 60 minutes
the level of sedation or alertness
the level of sedation or alertness with OAA/S scale
Measured: every 15 minutes from the arrival on the recovery room, up to 60 minutes
Postoperative Quality Recovery Scale (PQRS)
physiologic, nociceptive, emotive, cognitive and activities of daily living
Measured: at baseline (the day before surgery), at 1 hour after surgery, at 6 hours after surgery, at 24 hours after surgery and at 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seongwook Jeong, Chonnam National University Hospital
- Investigators
- SEONGWOOK JEONG, MD, PhD., Principal investigator, Chonnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601508
- Sponsor's protocol ID
- CNUHH-2015-135
- Acronym
- MISPCNUHH
- Status last verified
- Nov 2015
- First submitted
- 3 Nov 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Design, Single-center Study to Compare of Surgical Condition and Postoperative Complications With Moderate and Deep Neuromuscular Blockade in Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT02601508
- Acronym / sponsor ID
- MISPCNUHH / CNUHH-2015-135
- Conditions
- Neuromuscular Blockade
- Keywords
- deep NM block, Surgeon's satisfaction, bridion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 10 Nov 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 is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.
Detailed description
Neuromuscular blocking agents (NMBAs) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. In an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (TOF) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. It has been called moderate neuromuscular blockade (mNMB) condition. Nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. If any hypothetical advantages of deep neuromuscular blockade (dNMB) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modarate Blockade Group | Active comparator | Drug: cis-atracuriumNeuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine \& glycopyrrolate will be given for the recovery. |
| Deep Blockade Group | Experimental | Drug: RocuroniumNeuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.
Key exclusion criteria (7 listed)
- Known allergy to rocuronuim, cisatracurium or sugammadex
- Significant liver or kidney dysfunction
- Any neuromuscular disease
- Pregnant or breast feeding
- Indication for rapid sequence induction
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 |
|---|---|---|
| RocuroniumAlso: Esmeron®Continuous infusion of rocuronium for PTC 1 + Sugammadex | Drug | Deep Blockade Group |
| cis-atracuriumAlso: Nimbex®Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine \& Glycopyrrolate | Drug | Modarate Blockade Group |
Primary outcome
Surgical rating SCORE(SRS)
Time frame: every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery
excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1)
6 secondary outcomes
Respiratory rate
Time frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
peripheral arterial oxygen saturation
Time frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
visual analogue scale (VAS) for pain
Time frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
occurrence of nausea or vomiting
Time frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
the level of sedation or alertness
Time frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
Postoperative Quality Recovery Scale (PQRS)
Time frame: at baseline (the day before surgery), at 1 hour after surgery, at 6 hours after surgery, at 24 hours after surgery and at 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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.
Shiyoung JEONG, MD contact
SEONGWOOK JEONG, MD, PhD. principal investigator
Chonnam University Hospital
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 and cis-atracurium in people with Neuromuscular Blockade, run by Chonnam National University Hospital 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 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 10 Nov 2015. 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 SEONGHEON LEE, MD, PhD (+82-10-8612-9548, headheadhead@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical rating SCORE(SRS) (time frame: every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery). 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 10 Nov 2015.