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 objective is to evaluate the (hypothetical) dose of…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rating of surgical conditions (SRS) during the abdominal phase of the
operation.
Secondary outcome
- Rating of SRS during thoracic phase of the operation. Number of on demand
boluses infused, indication of on demand bolus administration,
- Rating of anesthesia conditions including: 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.
- Cost analysis: amount of rocuronium used (mg); Dose of sugammadex needed
(mg), time to reversal, duration of surgery, hypothetical need for need for
post-operative ventilation (%).
Background summary
Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure
where the use of deep neuromuscular block (NMB) may increase field visibility
and anesthesia conditions. However, the positioning of the patient (prone and
supine with both arms against the body) during this procedure often prevents
accurate train-of-four measurement to evaluate the depth of neuromuscular
block. Under these conditions, boluses of muscle relaxants are often given
randomly or on indication only, at the discretion of the surgeon or
anesthesiologist. Alternatively, continuous infusion of rocuronium can be used
but this might result into a deep NMB at the end of surgery. To optimize
anastomotic conditions, rapid extubation of the patient is preferred to
continuous postoperative mechanical ventilation on the ICU but neuromuscular
antagonists are often needed. The use of neostigmine for deep NMB has a high
risk of incomplete reversal but may also be contraindicated for moderate NMB
because of its cholinergic effects on smooth muscle that may endanger the
anastomotic patency of the neo-esophagus. Sugammadex is a safe and effective
alternative but comes with high costs and should be used at the lowest dose
possible. This might be a reason that the administration of rocuronium on
indication only is preferred under these circumstances. The use of *on demand*
as compared to deep NMB has never been evaluated during thoracoscopy in prone
positioning. This study evaluates the use of two muscle relaxant regimes on
operating and anesthesia conditions and the dose of sugammadex needed to
reverse NMB in patients undergoing thoracolaparoscopic oesophageal resection.
They will either have the Ivor Lewis (intra-thoracic anastomosis) or the
McKeown (left cervical anastomosis) approach.
Study 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 objective is to evaluate the (hypothetical) dose of sugammadex needed
in both groups in an economical perspective.
Another secondary objective is to compare the intra-operative cardiac and
respiratory incidents and post-operative complication rate of both groups.
Study design
Single-center randomized controlled double-blinded trial.
Intervention
Treatment allocation will be done in a double blinded fashion (both surgeon as
anesthesiologist), standard (on indication vs deep neuromuscular block).
Blinding will be done by a computerized randomization code. The medication is
supplied by the researcher to the (blinded) anesthesiologist in charge of the
patient. Patients are randomized to receive either continuous infusion of
rocuronium 0.6 mg/kg/hr or continuous infusion of NaCl 0.9% 0.6 ml/kg/hr. If
indicated by either surgeon or anesthesiologist, patients can receive *on
demand* doses of open label rocuronium 0.20 mg/kg, i.e. a single bolus from
hand is given.
Study burden and risks
We expect no burden or additional risks for patients. Deblinding of groups will
be done if necessary. Residual muscular relaxation will be antagonized with
sugammadex in both groups.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
All patients for laparothoracoscopic oesophagus cardia resection (Ivor Lewis or McKeown procedure)
Exclusion criteria
Age < 18, or pregnancy, known allergies for aminosteroid-type muscle relaxants or sugammadex.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2014-002147-18-NL |
CCMO | NL49503.018.14 |