Renal Disease Clinical Trial
Official title:
Effect of Deep BLock on Intraoperative Surgical Conditions, Perioperative Hemodynamic Status and Respiratory Parameters Following Reversal With Sugammadex in Patients Undergoing Laparoscopic Renal and Prostate Surgery.
Rationale: A deep neuromuscular block is often associated with improved surgical conditions
especially in laparoscopic surgery. However, a deep block comes at the expense of a variety
of items that may conflict with the use of a deep surgical muscle blockade including a long
recovery phase, the need for muscle reversal, postoperative ventilation, impaired
postoperative breathing. With the introduction of Sugammadex there is now the possibility to
reverse an even deep surgical block. This may overcome most if not all of the issues
mentioned.
Objective: To assess whether a deep neuromuscular block provides better surgical conditions
than a moderately deep block as derived from a surgical rating score.
Study design: Single center, double-blind randomized controlled trial. Study population: 24
ASA I-III patients scheduled for laparoscopic renal (n=12, GROUP 1) or prostatic surgery
(n=12, GROUP 2).
Intervention: In both GROUP 1 and GROUP 2, 6 six patients will receive neuromuscular
blockade according to current practice (atracurium (bolus) plus mivacurium (cont. infusion))
aimed at a moderately deep neuromuscular block (1-2 twitches in the Train of Four (TOF)
monitor). The other six will receive a bolus plus continuous infusion with rocuronium aimed
at a deep neuromuscular block (1-2 twitches post tetanic count (PTC)). All surgical
procedures will be performed by one surgeon.
Main study parameters/endpoints: To study the surgical conditions in patients undergoing
laparoscopic renal or prostate surgery during deep versus less deep neuromuscular block as
assessed by the surgical rating score.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Compared to current practice there will be no additional risk.
Surgical conditions in laparoscopic surgery are largely determined by the degree of
neuromuscular relaxation during surgery. Especially in procedures which are confined to a
narrow working field such as renal and prostatic laparoscopic surgery, deep neuromuscular
relaxation may be beneficial. Until recently however, deep neuromuscular block (1-2 twitches
post tetanic count) came at the expense of a variety of items that conflicted with its use.
Occurrence of postoperative residual neuromuscular blockade after deep neuromuscular block
was a common adverse event. Residual neuromuscular block is a risk factor for developing
airway obstruction and pulmonary complications such pneumonia and atelectasis. The use of
acetylcholinesterase inhibitors, like neostigmine, as a traditional neuromuscular blocking
reversal agent, have a slow onset of action. Side effects due to muscarine receptor
stimulation are bradycardia, hypersalivation, nausea and vomiting. Coadministration of a
muscarine agonist like atropine is often necessary to address the heart rate-related side
effects of neostigmine. Atropine, however, in itself may induce other side effects.
Rapid, safe and complete reversal of neuromuscular blockade was not possible until the
discovery of Sugammadex. Sugammadex is a modified y-cyclodextrin. It was developed to
selectively bind free plasma rocuronium, a non-depolarizing steroidal neuromuscular blocking
agent. By binding free rocuronium, less rocuronium becomes available at the neuromuscular
junction to bind to the muscarine receptor. Non-depolarizing neuromuscular blocking agents
(NMBA's) block the muscarine receptor at the neuromuscular junction, making them unavailable
to acetylcholine based signal transmission. Sugammadex has proven to rapidly and safely
reverse rocuronium and vecuronium. Even high dose rocuronium (1.2 mg/kg and continuous
rocuronium infusion used to achieve deep neuromuscular blockade can safely be reversed by
Sugammadex.
Theoretically, the availability of Sugammadex makes it possible to use deep neuromuscular
block (DNB) during surgery to improve surgical conditions without the occurrence of the
above-mentioned adverse events. The use of DNB to improve surgical conditions, however, has
not yet been evaluated. The investigators therefore aim to investigate the use of rocuronium
induced-DNB in renal and prostatic laparoscopic surgery. Current anesthesiologic practice
during these procedures in the LUMC consists of an intravenous (propofol) or volatile
(sevoflurane) anesthetic combined with mivacurium and atracurium to achieve a moderately
deep neuromuscular block (0-2 twitches TOF). Reversal of NMB is by the neostigmine atropine
combination. In the current study the investigators will assess the effect of a DNB (1-2
twitches post tetanic count) using a continuous rocuronium infusion on surgical conditions.
After surgery Sugammadex 4 mg/kg will be used to safely and rapidly reverse the
neuromuscular blockade within 5-min.
The main end-point of the study is the effect of the deep block on the surgical conditions.
The investigators will study these conditions using two methods. (1) Assessment of the
surgical condition by the operating surgeon (all surgeries will be performed by one
surgeon), using a 5-point rating surgical rating scale from 1 (= extremely poor surgical
condition) to 5 = optimal surgical condition. (2) Video images, used by the surgeon to
perform the surgery, will be rated by a team of surgical and non-surgical experts. Apart
from the additional scoring data, this approach allows for the validation of the surgical
rating scale.
Minor end-points of the study are (1) measurement of hemodynamics during surgery using a
non-invasive cardiac output and blood pressure device. Assuming that intra-abdominal
pressure will affect the venous return and hence cardiac output during surgery, a deep
neuromuscular block might affect the hemodynamic parameters positively; (2) measurement of
respiration, pain, and alertness in the recovery room to assess whether reversal with
Sugammadex influences these parameters positively compared to neostigmine/atropine reversal.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03672110 -
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen
|
Phase 3 | |
Completed |
NCT01545531 -
Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance
|
N/A | |
Recruiting |
NCT05700903 -
Contributions to Hypertension With Androgen Deprivation Therapy
|
Phase 4 | |
Completed |
NCT03717883 -
ADPKD Alterations in Hepatic Transporter Function
|
||
Withdrawn |
NCT04556721 -
A Pharmacokinetic Study of Sugammadex in Dialysis Patients
|
Phase 1 | |
Active, not recruiting |
NCT04078750 -
PLATO - Medication Adherence in Transplant Recipients
|
N/A | |
Not yet recruiting |
NCT04531124 -
Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives
|
||
Completed |
NCT03107195 -
Biokinetics Study of Tc-99m DMSA in Pediatric Molecular Imaging
|
||
Completed |
NCT03463148 -
Validation of a Sensor for Non-Invasive Measurements
|
||
Recruiting |
NCT03578523 -
Renal MR Feasibility in Renal Disease
|
||
Withdrawn |
NCT01468259 -
A Multi-Center, Open-Label Study
|
Phase 1 | |
Completed |
NCT01256983 -
Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation
|
Phase 0 | |
Completed |
NCT06070337 -
H-Guard Pilot Safety Evaluation in Haemodialysis Patients
|
N/A | |
Completed |
NCT05593211 -
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
|
N/A | |
Completed |
NCT03242343 -
VasQ External Support for Arteriovenous Fistula
|
N/A | |
Completed |
NCT03438123 -
Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera
|
N/A | |
Completed |
NCT01334333 -
Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients
|
Phase 4 | |
Recruiting |
NCT05443321 -
Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes
|
N/A | |
Completed |
NCT04407182 -
Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19
|
Phase 2 | |
Not yet recruiting |
NCT06419270 -
Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
|