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Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy (DEPTH)

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ClinicalTrials.gov Identifier: NCT02320734
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Neuromuscular Block Esophageal Cancer Surgery Drug: Rocuronium Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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
Study Start Date : February 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: deep neuromuscular relaxation
continuous infusion of rocuronium 0.6 mg/kg/hr (group 1). On demand bolus rocuronium can be given if demanded by anesthesiologist or surgeon
Drug: Rocuronium
Rocuronium given continuously to reach deep neuromuscular block
Other Name: Esmeron

No Intervention: on demand neuromuscular relaxation
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.



Primary Outcome Measures :
  1. Rating of surgical conditions (SRS) during the abdominal phase of the operation. [ Time Frame: during operation ]

Secondary Outcome Measures :
  1. Rating of SRS during thoracic phase of the operation. [ Time Frame: during operation ]
  2. Number of on demand boluses infused, indication of on demand bolus administration [ Time Frame: during operation ]
  3. Rating of anesthesia conditions [ Time Frame: during operation ]
    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

  4. 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 ]
    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(%).

  5. Number of correct estimates of group randomization by surgeons [ Time Frame: directly after operation ]
    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.


Other Outcome Measures:
  1. length of stay ICU/PACU [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  2. need for re-intubation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  3. post-operative surgical complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  4. VAS-scores [ Time Frame: 24-hours post operation ]
  5. Abdominal and thoracic insufflation pressures [ Time Frame: During operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor Lewis or McKeown variant)
  • Written informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320734


Locations
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Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Merck Sharp & Dohme Corp.
Investigators
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Study Chair: Markus W Hollmann, prof Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Denise P Veelo, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: D.P.Veelo, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02320734     History of Changes
Other Study ID Numbers: 2014-211
2014-002147-18 ( EudraCT Number )
MISP51412 ( Other Grant/Funding Number: Merck Sharp & Dohme BV )
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Keywords provided by D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
surgical rating scale
neuromuscular relaxation
Anaesthesia
minimally invasive esophagectomy
Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs