Clinical trial NCT03170661: Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
Official title: Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Conditions
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-05-31
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.

Detailed description: Neuromuscular blocking agents (NMBAs) are routinely administered during general anaesthesia to facilitate endotracheal intubation and to optimize surgical conditions. Increasing data suggest superiority of a deep neuromuscular block (defined by a post-tetanic count of 1-2 twitches) in creating optimal working conditions for the surgical team. However, it is unknown whether other aspects of the anaesthetic technique, most notably the choice of anaesthetic (for example, total intravenous versus inhalational anaesthesia), influence the relationship between the depth of the neuromuscular block and surgical conditions, particularly in laparoscopic surgery. Volatile anaesthetics are known for their ability to potentiate neuromuscular blocking agents an effect that is less existent with propofol. We previously showed that surgical working conditions in laparoscopic surgery during propofol anaesthesia are highly reliant on the depth of the neuromuscular block. Whether such a relationship also exists for inhalational anaesthetics, is unknown. To investigate this, we conducted a prospective, randomized, double blind study in which patients scheduled for laparoscopic renal surgery were randomized to receive either a moderate or a deep neuromuscular block during sevoflurane anaesthesia. The primary outcome was the intraoperative surgical condition assessed by a surgeon using the validated Leiden-Surgical Rating Scale. We hypothesized that the use of an inhalational anaesthetic would obviate the need for a deep NMB due to its intrinsic muscle relaxant potentiating properties to produce optimal working conditions.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
* American Society of Anesthesiologists (ASA) class I-III
* \> 18 years of age;
* Ability to give oral and written informed 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 or are currently breast feeding;
* Renal insufficiency, as defined by glomerular filtration rate \< 30 ml/h creatinine.
* Previous retroperitoneal surgery at the site of the current surgery.
* Body mass index \> 35 kg/m2

Primary outcomes:
measure: Leiden Surgical Rating Scale
timeFrame: during surgery
Secondary outcomes:
measure: Postoperative Measurements and Outcomes; Pain Scores
timeFrame: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
measure: Intraoperative Hemodynamic Conditions
timeFrame: Perioperative measurements at 15 minute interval (on average during 3 hours)
measure: Postoperative Measurements and Outcomes; Sedation Levels
timeFrame: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
measure: Postoperative Measurements and Outcomes; Saturation
timeFrame: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
measure: Intraoperative Nociception Level
timeFrame: Perioperative measurements at 15 minute interval (on average during 3 hours)
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: LUMC
name: Albert Dahan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: