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Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

Effect of Deep Neuromuscular Blockade on Surgical Conditions and Recovery After Robotic Radical Prostatectomy: a Prospective Randomized Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02513693
Enrollment
80
Registered
2015-08-03
Start date
2015-07-31
Completion date
2016-03-31
Last updated
2015-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

Anesthesia, Rocuronium, Sugammadex, Neostigmine, TOF, Radical Prostatectomy, Robotic Surgery, Accelerometry

Brief 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).

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.

Interventions

DRUGStandard neuromuscular blockade

Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.

Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.

Sponsors

University Hospital Olomouc
CollaboratorOTHER
Masaryk Hospital Usti nad Labem
CollaboratorOTHER
Palacky University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Surgical conditionEvery 15 minutes during surgery until final sutureSurgical rating score (SRS) - surgical condition will be evaluated by surgeon every 15 minutes on predefined five point scale (excellent - above average - average - below average - poor). For each patient, the final score will be the average of all 15 min SRS values.

Secondary

MeasureTime frameDescription
Quality of recovery2 monthsSpeed of clinical recovery by using Post-Operative Quality Recovery Scale (www.pqrsonline.org). PQRS will be evaluated at following time points: preoperatively, day (D) 1, D3, D7, month (M) 1, M2.
Ready to leave operating room (OR) timePeriod of patient's presence at ORReady to leave OR time will be defined as a time period (in minutes) from the time point of completing surgery to the time point, when patient is ready to leave OR to the facility providing postanesthesia care.

Countries

Czechia

Contacts

Primary ContactMilan Adamus, MD,PhD,MBA
milan.adamus@seznam.cz+420588442705
Backup ContactLenka Doubravská, MD
lenadoub@seznam.cz+420588445979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026