Neuromuscular BlockPhase 4DEPTHNCT02320734
Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy
A Phase 4 study testing Rocuronium in people with Neuromuscular Block and Esophageal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia conditions. Under these conditions, boluses of muscle relaxants can be given on indication only OR by continuous infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Block, Esophageal Cancer, Surgery
- 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
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor Lewis or McKeown variant)
- Written informed consent
Who cannot join
- pregnancy
- Known allergies for aminosteroid-type muscle relaxants or sugammadex.
- Severe kidney dysfunction (GFR < 30), patients on dialysis
- Liver function disorders
- Myasthenia Gravis or other (neuro)muscular diseases
- Patients with carcinomatosis
- Use of anti-epileptics and lithium or drugs containing Kinin
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
About this study
Official title: A Randomized Controlled Double-blinded Trial Comparing the Effect of on Demand vs Deep Neuromuscular Relaxation on Rating of Surgical and Anesthesia Conditions in Patients Undergoing Thoraco-laparoscopic Esophagectomy
Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia conditions. Under these conditions, boluses of muscle relaxants can be given on indication only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex are needed to reverse NMB at the end of surgery.
Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed in both groups in an economical perspective and to compare the intra-operative cardiac and respiratory incidents and post-operative complication rate of both groups.
Read more
Study design: a single-center randomized controlled double-blinded intervention study.
Study population: All patients > 18 years to undergo a thoracolaparoscopic esophageal resection.I Intervention: Patients are randomized to receive either continuous infusion of rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.
Main study parameters/endpoints: The primary outcome parameter of this study is the SRS during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose of Sugammadex needed in both groups to reach a TOF of > 90%, duration of surgery, a cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.
- Conditions
- Neuromuscular Block, Esophageal Cancer, Surgery
- Being tested
- Rocuronium
- Keywords
- surgical rating scale, neuromuscular relaxation, Anaesthesia, minimally invasive esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Esmeron
Rocuronium given continuously to reach deep neuromuscular block
| Study group | Role | What they receive |
|---|---|---|
| deep neuromuscular relaxation | Active comparator | continuous infusion of rocuronium 0.6 mg/kg/hr (group 1). On demand bolus rocuronium can be given if demanded by anesthesiologist or surgeon Receives: Drug: Rocuronium |
| on demand neuromuscular relaxation | No intervention | continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2) On demand bolus of Rocuronium will be given when demanded by anesthesiologist or surgeon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of surgical conditions (SRS) during the abdominal phase of the operation.
Measured: during operation
Secondary outcomes (5)
Rating of SRS during thoracic phase of the operation.
Measured: during operation
Number of on demand boluses infused, indication of on demand bolus administration
Measured: during operation
Rating of anesthesia conditions
peak and mean respiratory pressure, incidence peak insufflation pressure >35 mmHg. Depth of NBM at the end of surgery. Time until spontaneous breathing, time until extubation. Peroperative cardiac and respiratory incidents, peroperative surgical complications.Tiem to reversal of NMB, % of recurarisation
Measured: during operation
Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.
amount of rocuronium used (mg); Dose of sugammadex needed (mg), duration of surgery, hypothetical need for post-operative ventilation if sugammadex would not be available(%).
Measured: during operation and an average of 4 weeks thereafter
Number of correct estimates of group randomization by surgeons
Surgeons will guess in which group the patient was randomized (%) and the reason for this choice will be registrated. Accordingly we can estimate whether the surgeons complaints of inadequate NMB are justified and additionally, the chance of bias affecting main outcome parameter.
Measured: directly after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Markus W Hollmann, prof, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Denise P Veelo, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320734
- Sponsor's protocol ID
- 2014-211
- Other IDs
- 2014-002147-18, MISP51412, 2014
- Acronym
- DEPTH
- Status last verified
- Sep 2016
- First submitted
- 12 Dec 2014
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Veelo DP, Gisbertz SS, Binnekade JM, Hannivoort RA, Bosman JA, Geerts BF, Blobner M, van Berge Henegouwen MI, Hollmann MW. On-demand versus continuous rocuronium infusion for deep neuromuscular relaxation in patients undergoing thoraco-laparoscopic esophagectomy: a randomized-controlled clinical trial (DEPTH). Can J Anaesth. 2019 Sep;66(9):1062-1074. doi: 10.1007/s12630-019-01373-0. Epub 2019 Apr 25.
PubMed 31025258Veelo DP, Gisbertz SS, Hannivoort RA, van Dieren S, Geerts BF, van Berge Henegouwen MI, Hollmann MW. The effect of on-demand vs deep neuromuscular relaxation on rating of surgical and anaesthesiologic conditions in patients undergoing thoracolaparoscopic esophagectomy (DEPTH trial): study protocol for a randomized controlled trial. Trials. 2015 Aug 5;16:331. doi: 10.1186/s13063-015-0849-0.
PubMed 26242177
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Double-blinded Trial Comparing the Effect of on Demand vs Deep Neuromuscular Relaxation on Rating of Surgical and Anesthesia Conditions in Patients Undergoing Thoraco-laparoscopic Esophagectomy
- ClinicalTrials.gov ID
- NCT02320734
- Acronym / sponsor ID
- DEPTH / 2014-211
- Conditions
- Neuromuscular Block, Esophageal Cancer, Surgery
- Keywords
- surgical rating scale, neuromuscular relaxation, Anaesthesia, minimally invasive esophagectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Dec 2014 (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.
Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia conditions. Under these conditions, boluses of muscle relaxants can be given on indication only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex are needed to reverse NMB at the end of surgery.
Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed in both groups in an economical perspective and to compare the intra-operative cardiac and respiratory incidents and post-operative complication rate of both groups.
Study design: a single-center randomized controlled double-blinded intervention study.
Study population: All patients > 18 years to undergo a thoracolaparoscopic esophageal resection.I Intervention: Patients are randomized to receive either continuous infusion of rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.
Main study parameters/endpoints: The primary outcome parameter of this study is the SRS during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose of Sugammadex needed in both groups to reach a TOF of > 90%, duration of surgery, a cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep neuromuscular relaxation | Active comparator | Drug: Rocuroniumcontinuous infusion of rocuronium 0.6 mg/kg/hr (group 1). On demand bolus rocuronium can be given if demanded by anesthesiologist or surgeon |
| on demand neuromuscular relaxation | No intervention | –continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2) On demand bolus of Rocuronium will be given when demanded by anesthesiologist or surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor Lewis or McKeown variant)
- Written informed consent
Key exclusion criteria (7 listed)
- pregnancy
- Known allergies for aminosteroid-type muscle relaxants or sugammadex.
- Severe kidney dysfunction (GFR < 30), patients on dialysis
- Liver function disorders
- Myasthenia Gravis or other (neuro)muscular diseases
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: EsmeronRocuronium given continuously to reach deep neuromuscular block | Drug | deep neuromuscular relaxation |
Primary outcome
Rating of surgical conditions (SRS) during the abdominal phase of the operation.
Time frame: during operation
5 secondary outcomes
Rating of SRS during thoracic phase of the operation.
Time frame: during operation
Number of on demand boluses infused, indication of on demand bolus administration
Time frame: during operation
Rating of anesthesia conditions
Time frame: during operation
Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.
Time frame: during operation and an average of 4 weeks thereafter
Number of correct estimates of group randomization by surgeons
Time frame: directly after operation
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 19 Sep 2016.
- Derived from this study: PubMed 31025258Veelo DP, Gisbertz SS, Binnekade JM, Hannivoort RA, Bosman JA, Geerts BF, Blobner M, van Berge Henegouwen MI, Hollmann MW. On-demand versus continuous rocuronium infusion for deep neuromuscular relaxation in patients undergoing thoraco-laparoscopic esophagectomy: a randomized-controlled clinical trial (DEPTH). Can J Anaesth. 2019 Sep;66(9):1062-1074. doi: 10.1007/s12630-019-01373-0. Epub 2019 Apr 25.
- Derived from this study: PubMed 26242177Veelo DP, Gisbertz SS, Hannivoort RA, van Dieren S, Geerts BF, van Berge Henegouwen MI, Hollmann MW. The effect of on-demand vs deep neuromuscular relaxation on rating of surgical and anaesthesiologic conditions in patients undergoing thoracolaparoscopic esophagectomy (DEPTH trial): study protocol for a randomized controlled trial. Trials. 2015 Aug 5;16:331. doi: 10.1186/s13063-015-0849-0.
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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.
Markus W Hollmann, prof study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Denise P Veelo, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Neuromuscular Block and Esophageal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 19 Sep 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 Netherlands. 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?
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?
Rating of surgical conditions (SRS) during the abdominal phase of the operation. (time frame: during operation). 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 NCT02320734, which also lists 2 linked publications.
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 19 Sep 2016.