Laparoscopic Renal SurgeryPhase 4NCT02185339
Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics
A Phase 4 study testing Rocuronium in people with Laparoscopic Renal Surgery and Laparoscopy, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Renal Surgery, Laparoscopy, Muscle Relaxation
- What is being tested?
- Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II patients scheduled to undergo laparoscopic renal surgery
Who cannot join
- BMI ≥35 kg/m2
- Known neuromuscular disease
- History of chronic obstructive pulmonary disease
- Asthma
- Pneumothorax
- Bronchopleural fistula
Show all 11Show fewer
- Previous lung surgery
- Previous retroperitoneal surgery
- Hemodynamic instability
- History of cardiopulmonary disease
- Renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study
The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.
- Conditions
- Laparoscopic Renal Surgery, Laparoscopy, Muscle Relaxation
- Being tested
- Rocuronium
- Keywords
- Respiratory mechanics, Respiratory function test, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Esmeron®
Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.
RocuroniumDrug
Also called Esmeron®
Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.
| Study group | Role | What they receive |
|---|---|---|
| dNMB group | Experimental | For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. Receives: Drug: Rocuronium |
| mNMB group | Active comparator | For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count >2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracopulmonary Compliance
Was measured with a patient spirometry monitor through a flow sensor.
Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).
Measured: intraoperative
Secondary outcomes (4)
Arterial Oxygen Tension/Inspired Oxygen Fraction
Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Measured: intraoperative
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Measured: intraoperative
Estimated Dead Space
Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Measured: intraoperative
Pulmonary Shunt
Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laparoscopic Renal SurgeryStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Sanghyun Hong, Seoul St. Mary's Hospital
- Investigators
- Sang-Hyun Hong, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185339
- Sponsor's protocol ID
- dNMBonResp
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2014
- Last updated
- 25 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study
- ClinicalTrials.gov ID
- NCT02185339
- Acronym / sponsor ID
- dNMBonResp
- Conditions
- Laparoscopic Renal Surgery, Laparoscopy, Muscle Relaxation
- Keywords
- Respiratory mechanics, Respiratory function test, Hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Posted 24 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dNMB group | Experimental | Drug: RocuroniumFor patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. |
| mNMB group | Active comparator | Drug: RocuroniumFor patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count >2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I or II patients scheduled to undergo laparoscopic renal surgery
Key exclusion criteria (11 listed)
- BMI ≥35 kg/m2
- Known neuromuscular disease
- History of chronic obstructive pulmonary disease
- Asthma
- Pneumothorax
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®Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2. | Drug | dNMB group |
| RocuroniumAlso: Esmeron®Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2. | Drug | mNMB group |
Primary outcome
Thoracopulmonary Compliance
Time frame: intraoperative
Was measured with a patient spirometry monitor through a flow sensor. Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).
4 secondary outcomes
Arterial Oxygen Tension/Inspired Oxygen Fraction
Time frame: intraoperative
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
Time frame: intraoperative
Estimated Dead Space
Time frame: intraoperative
Pulmonary Shunt
Time frame: intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sang-Hyun Hong, MD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium in people with Laparoscopic Renal Surgery and Laparoscopy, run by Seoul St. Mary's 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 11 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 25 Jul 2016. 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.
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?
Yes. Results are posted in the registry (first posted 24 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Thoracopulmonary Compliance (time frame: intraoperative). 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 25 Jul 2016.