Neuromuscular BlockadeNCT04174222
The Effect of Deep Neuromuscular Blockade on Respiratory Mechanics
A study testing Moderate NMB and Deep NMB in people with Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a randomized, controlled, double-blinded, and parallel design study. A total 58 patients were randomized to receive a deep block or a moderate block scheduled for elective robot assisted laparoscopic radical prostatectomy. Intraoperative peak inspiratory pressure and plateau pressure are assessed. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Moderate NMB and Deep NMB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Nov 2019to 30 Jun 2021
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo elective robot assisted radical prostatectomy,
- American Society of Anesthesiologists grade 1 or 2
Who cannot join
- Refuse to participate to the study
- history of neuromuscular diseases
- known allergy to rocuronium, sugammadex
- patients scheduled for intensive care unit transfer
- Body Mass Index > 30 kg/m2
- Severe renal function impairment
- Moderete or severe obstructive/restrictive lung disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: The Effect of Deep Neuromuscular Blockade During Robotic Assisted Radical Prostatectomy on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Complications : a Prospective Randomized Controlled Trial
This study is a randomized, controlled, double-blinded, and parallel design study. A total 58 patients were randomized to receive a deep block or a moderate block scheduled for elective robot assisted laparoscopic radical prostatectomy. Intraoperative peak inspiratory pressure and plateau pressure are assessed.
Read the detailed description
Patients >18 years of age with an america society of anesthesiologist classification of I or II who are scheduled to undergo elective robot assisted laparoscopic radical prostatectomy are included. The exclusion criteria are a history of neuromuscular, renal, or hepatic disease, known allergy to rocuronium or sugammadex. Patients are randomized to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0). In the operating room, routine monitoring is performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry. Additionally, acceleromyography are applied to monitor the response of the adductor pollicis muscle. After the induction of anesthesia with propofol and before rocuronium administration, the TOF-Watch-SX is calibrated and stabilised, and a series of train-of-four (TOF) measurements are documented every 1 min. Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation. Anesthesia is maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index. Intravenous rocuronium (5-10 mg) is used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade. Peak inspiratory pressure and plateau pressure are recorded until 1 hour after pneumoperitoneum. At the end of the operation, the surgeon rated the surgical condition on a 5-point scale. Patients are reversed with intravenous sugammadex at 2 or 4 mg/kg. Postoperative pulmonary complications (SpO2 <100%, RR<8, atelectasis) are assessed and recorded.
- Conditions
- Neuromuscular Blockade
- Being tested
- Moderate NMB, Deep NMB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate NMBOther
Neuromuscular block was maintained at train of four count 1-2.
Deep NMBOther
Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.
| Study group | Role | What they receive |
|---|---|---|
| Moderate block | Active comparator | 5-10mg rocuronium is administered to maintain train-of-four count 1-2. At the end of surgery, sugammadex 2mg/kg is administered IV for reversal of neuromuscular block. Receives: Other: Moderate NMB |
| Deep block | Experimental | 5-10mg rocuronium is administered to maintain train-of-four count 0, and post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block Receives: Other: Deep NMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak inspiratory pressure
measured through ventilator
Measured: until 1 hour after pneumoperitoneum
Secondary outcomes (5)
plateau pressure
measured through ventilator
Measured: until 1 hour after pneumoperitoneum
dynamic lung compliance
Tidal volume/(Peak inspiratory pressure - PEEP)
Measured: until 1 hour after pneumoperitoneum
static lung compliance
Tidal volume/(Plateau pressure - PEEP)
Measured: until 1 hour after pneumoperitoneum
5-point surgical rating scale
Rated by the surgeon who is in charge of the patient's operation and is blind to the patient's group assignment. (1 = excellent, 2 = good, 3 = acceptable, 4 = poor, 5 = extremely poor)
Measured: 1 min at the end of surgery
Postoperative pulmonary complications
SpO2 <90% or RR < 8/min, atelectasis confirmed by Chest X ray
Measured: postoperative 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start22 Nov 2019
- Primary completion30 Aug 2020
- Study completion30 Jun 2021
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Koo, Seoul National University Hospital
- Investigators
- Chang-Hoon Koo, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174222
- Sponsor's protocol ID
- RALP-PIP
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Neuromuscular Blockade During Robotic Assisted Radical Prostatectomy on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Complications : a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04174222
- Acronym / sponsor ID
- RALP-PIP
- Conditions
- Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Nov 2019 (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 is a randomized, controlled, double-blinded, and parallel design study. A total 58 patients were randomized to receive a deep block or a moderate block scheduled for elective robot assisted laparoscopic radical prostatectomy. Intraoperative peak inspiratory pressure and plateau pressure are assessed.
Detailed description
Patients >18 years of age with an america society of anesthesiologist classification of I or II who are scheduled to undergo elective robot assisted laparoscopic radical prostatectomy are included. The exclusion criteria are a history of neuromuscular, renal, or hepatic disease, known allergy to rocuronium or sugammadex. Patients are randomized to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0). In the operating room, routine monitoring is performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry. Additionally, acceleromyography are applied to monitor the response of the adductor pollicis muscle. After the induction of anesthesia with propofol and before rocuronium administration, the TOF-Watch-SX is calibrated and stabilised, and a series of train-of-four (TOF) measurements are documented every 1 min. Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation. Anesthesia is maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index. Intravenous rocuronium (5-10 mg) is used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade. Peak inspiratory pressure and plateau pressure are recorded until 1 hour after pneumoperitoneum. At the end of the operation, the surgeon rated the surgical condition on a 5-point scale. Patients are reversed with intravenous sugammadex at 2 or 4 mg/kg. Postoperative pulmonary complications (SpO2 <100%, RR<8, atelectasis) are assessed and recorded.
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 |
|---|---|---|
| Moderate block | Active comparator | Other: Moderate NMB5-10mg rocuronium is administered to maintain train-of-four count 1-2. At the end of surgery, sugammadex 2mg/kg is administered IV for reversal of neuromuscular block. |
| Deep block | Experimental | Other: Deep NMB5-10mg rocuronium is administered to maintain train-of-four count 0, and post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo elective robot assisted radical prostatectomy,
- American Society of Anesthesiologists grade 1 or 2
Key exclusion criteria (7 listed)
- Refuse to participate to the study
- history of neuromuscular diseases
- known allergy to rocuronium, sugammadex
- patients scheduled for intensive care unit transfer
- Body Mass Index > 30 kg/m2
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 |
|---|---|---|
| Moderate NMBNeuromuscular block was maintained at train of four count 1-2. | Other | Moderate block |
| Deep NMBNeuromuscular block was maintained at train of four count 0 and post-tetanic count1-2. | Other | Deep block |
Primary outcome
Peak inspiratory pressure
Time frame: until 1 hour after pneumoperitoneum
measured through ventilator
5 secondary outcomes
plateau pressure
Time frame: until 1 hour after pneumoperitoneum
dynamic lung compliance
Time frame: until 1 hour after pneumoperitoneum
static lung compliance
Time frame: until 1 hour after pneumoperitoneum
5-point surgical rating scale
Time frame: 1 min at the end of surgery
Postoperative pulmonary complications
Time frame: postoperative 30 min
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 9 Dec 2021.
- 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.
Chang-Hoon Koo principal investigator
Seoul National University Bundang 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 Moderate NMB and Deep NMB in people with Neuromuscular Blockade, run by Seoul 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 2 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: finished, as of the sponsor's last update on 9 Dec 2021. 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?
Peak inspiratory pressure (time frame: until 1 hour after pneumoperitoneum). 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 9 Dec 2021.