Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
Information source: Palacky University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuromuscular Blockade
Intervention: Standard neuromuscular blockade (Drug); Deep neuromuscular blockade (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Palacky University Official(s) and/or principal investigator(s):
Milan Adamus, MD,PhD,MBA, Study Director, Affiliation: Department of Anesthesiology and Intensive Care Medicine Palacky University Olomouc Faculty of Medicine and Dentistry
Vladimir Cerny, MD,PhD,FCCM, Principal Investigator, Affiliation: J. E. Purkinje University, Masaryk Hospital, Usti nad Labem, Czech Republic, Dept. of Anesthesiology, Perioperative Medicine and Intensive Care
Overall contact:
Milan Adamus, MD,PhD,MBA, Phone: +420588442705, Email: milan.adamus@seznam.cz
Summary
Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and
clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a
neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between
optimal surgical conditions (sufficiently deep block) and capability to antagonize the block
rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep
neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous
recovery or reversal of the block with neostigmine, administration of sugammadex at the end
of the surgery will enable quick and consistent reversal of the block. Project is focused on
comparison of the parameters of deep and standard neuromuscular blockade - surgical
conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).
Clinical Details
Official title: Effect of Deep Neuromuscular Blockade on Surgical Conditions and Recovery After Robotic Radical Prostatectomy: a Prospective Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Surgical condition
Secondary outcome: Quality of recovery"Ready to leave operating room (OR)" time
Detailed description:
Balanced anesthesia is an anesthetic procedure of choice for intra-abdominal surgery. Main
components of this procedure are loss of consciousness, treatment of pain and appropriate
neuromuscular blockade (NMB). Peripheral neuromuscular blocking agents (NMBA) are drugs used
for muscle relaxation during balanced anesthesia. Their use plays essential role for
tracheal intubation, orotracheal tube tolerance, introduction of mechanical ventilation and
provision of calm surgical field.
In laparoscopic procedures, introduction of capnoperitoneum for good visibility in surgical
field is necessary. From anesthetic point of view this requirement can be met by adequate
muscle relaxation. After withdrawal of capnoperitoneum at the end of the surgery the
procedure is usually terminated quickly (this phase consists only from suture of a
peritoneum and the small incisions through which instruments were inserted). Spontaneous
recovery from NMB or usual reversal of the block by neostigmine are not fast and reliable
enough at this moment. During standard neuromuscular blockade the dosage of NMBA is a
compromise between optimal surgical conditions (sufficiently deep block) and capability to
antagonize the block rapidly at the end of the surgery. Introduction of sugammadex into
clinical praxis brings the potential to change this paradigm. With rocuronium, it is
possible to maintain deep neuromuscular blockade safely until the very end of the surgery
and unlike with spontaneous recovery or reversal of the block with neostigmine,
administration of sugammadex at the end of the surgery will enable quick and consistent
reversal of the block. Data about routine use of the deep block are rare, PubMed lists with
search strategy [(deep neuromuscular blockade) AND (laparoscopic surgery OR laparoscopy)] 11
references (January 12, 2015, www. pubmed. com).
Patients undergoing robotic radical prostatectomy will be randomized to two groups differing
in muscle relaxation strategy (standard vs. deep) and the type of antagonizing drug at the
end of the surgery (neostigmine vs. sugammadex). Relevant end-points and the differences
between groups with deep and standard neuromuscular blockade will be compared. Indication
and dosage of rocuronium, neostigmine and sugammadex correspond to manufacturers'
recommendations.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age over 18 years
- Informed consent
- Elective robotic radical prostatectomy
- American Society of Anesthesiologists (ASA) status 1-3
Exclusion Criteria:
- Age under 18 years
- American Society of Anesthesiologists (ASA) status over 3
- Indication for rapid sequence induction, signs of difficult airway severe
neuromuscular, liver or renal disease
- Known allergy to drugs used in the study
- Malignant hyperthermia (medical history)
Locations and Contacts
Milan Adamus, MD,PhD,MBA, Phone: +420588442705, Email: milan.adamus@seznam.cz
Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc, Olomouc 775 20, Czech Republic; Recruiting
Milan Adamus, MD,PhD,MBA, Phone: +420 588 442 705, Email: milan.adamus@seznam.cz
Lenka Doubravská, MD, Phone: +420 588 445 979, Email: lenadoub@seznam.cz
Dept. of Anesthesiology, Perioperative Medicine and Intensive Care, J. E. Purkinje University, Masaryk Hospital, Usti nad Labem 401 13, Czech Republic; Recruiting
Vladimir Cerny, MD,PhD,FCCM, Phone: +420 602 492 054, Email: cernyvla1960@gmail.com
Additional Information
Starting date: July 2015
Last updated: July 30, 2015
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