to study the effect of depth of neuromuscular block and nociception level guidance on hemodynamic variables during abdominal laparoscopic surgery
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anesthesie, laparoscopie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean arterial pressure at 30 minutes after installation of the pneumoperitoneum
Secondary outcome
Mean arterial pressure at all other time points
Left ventricular ejection fraction, stroke volume, systolic and diastolic
function, afterload and cardiac output
Stroke volume variation
Systemic vascular resistance
Haemodynamic instability score
Background summary
Many surgical procedures are performed using the laparoscopic approach.
However, insufflation of the abdomen (pneumoperitoneum) has detrimental
hemodynamic effects. The magnitude of haemodynamic changes after
pneumoperitoneum depend on several major variables: (1) insufflation pressure;
(2) patient position; (3) depth of anesthesia (4) nociception-antinociception
balance and (5) the level of neuromuscular block (NMB). Some of these variables
have been studied in the past, however new developments within the field of
anaesthesia now enable anaesthesiologists to apply deep neuromuscular blockade
and to balance nociception-antinociception during surgery. The effect of these
techniques on haemodynamic control during pneumoperitoneum are however not well
established. We will perform an experimental strategy study to evaluate the
effect of a goal directed anaesthesia strategy with deep NMB (PTC 1-2) and
nociception guided anesthesia regimen using the Nociception Level Index (NOL)
on relevant hemodynamic parameters during abdominal laparoscopic surgery.
Study objective
to study the effect of depth of neuromuscular block and nociception level
guidance on hemodynamic variables during abdominal laparoscopic surgery
Study design
prospective, randomized controlled strategy trial
Intervention
Patients in this group will receive deep NMB, aimed at PTC 1-2 during the
entire procedure. The NMB will be maintained with a continuous infusion of
rocuronium and reversed at the end with sugammadex. In addition, opioid dosing
will be guided using the nociception level index.
Study burden and risks
Patients will receive an arterial cannula in the radial artery for beat to beat
recordings of their hemodynamic variables. In addition, transesophageal
echocardiography will be performed. Both measurements give valuable information
of the patient*s hemodynamics and are commonly used in our department; they are
associated with a low risk of complications. In addition, because these
techniques are applied after patients are a sleep and removed before awakening,
there is no direct discomfort. Deep neuromuscular block, single shot
neuromuscular block and nociception monitoring are all standard of care at the
LUMC.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
ASA 1-3
Age > 18
Scheduled for laparoscopic or robotic abdominal surgery
Ability to give oral and written consent
Exclusion criteria
Known or suspected neuromuscular disorders impairing neuromuscular function;
Allergies to muscle relaxants, anesthetics or narcotics;
A (family) history of malignant hyperthermia;
Women who are or may be pregnant;
Preexisting cardiac disease (any);
Untreated or uncontrolled hypertension;
COPD gold 3 or higher
Any contradictions for TEE:
Preexistent esophageal pathology (stricture, tumor, diverticulum)
Any increased risk factor for upper gastro intestinal tract bleed:
History of GI surgery;
History of GI bleed;
Esophageal varices;
Gastric or esophageal inflammation;
Severe thrombocytopenia (less than 50k) or severely elevated INR (>4).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| Other | het protocol wordt geregistreerd op clinicaltrials.gov |
| CCMO | NL69290.058.19 |