Clinical trial NCT03039543: Neuromuscular Blockade During Transurethral Resection of Bladder Cancer
Official title: The Effect of Neuromuscular Blockade During Transurethral Resection of Bladder Cancer on Surgical Condition and Recovery Profiles : A Prospective, Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: MSD Korea Ltd.
First posted: 2017-02-01
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the use of sugammadex as a reversal agent may be associated with better endoscopic surgical condition and recovery profile compared with moderate NMB during TURB.

This study was designed to compare patients with deep neuromuscular blockade (NMB) with moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical condition and postoperative recovery.

Detailed description: Transurethral resection of the bladder tumor (TURB) is the mainstream treatment of bladder cancer. TURB may be performed under regional anesthesia or general anesthesia. During regional anesthesia for TURB, obturator nerve block should be performed to prevent adductor contraction and possible inadvertent bladder perforation. Additionally, some patients prefer not to be conscious during the surgery and patients with spinal deformity or previous spinal fusion surgery are prone to fail regional anesthesia. Therefore, general anesthesia with neuromuscular blockade (NMB) is frequently conducted for patients with TURB.

During general anesthesia for TURB, NMB is needed for intubation and optimal endoscopic surgical condition via obturator nerve block. TURB is a relatively short procedure but patients with NMB usually need sufficient time to be reversed with the conventional NMB reversal agents (anticholinesterases). Additionally, inadequate reversal from NMB may result in respiratory complication during recovery. Sugammadex, a newer reversal agent, is a selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced NMB. With the introduction of sugammadex, immediate reversal of deep NMB has become possible without residual NMB.

Several previous studies evaluated the effect of NMB on surgical condition for relative short surgeries such as laparoscopic cholecystectomy or laryngeal micro-surgery. They suggested that deep NMB and reversal with sugammadex improved surgical condition without postop respiratory complications. TURB is a urological endoscopic procedure performed in a narrow bladder space but the beneficial effects of deep NMB with sugammadex reversal for TURB have not been thoroughly evaluated. We hypothesized that deep NMB and the use of sugammadex as a reversal agent may be associated with better endoscopic surgical condition compared with moderate NMB during TURB. Therefore, this study was designed to compare deep NMB with moderate NMB during TURB in terms of surgical condition and recovery profiles in patients with general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients aged more than 18 years
* American Society of Anesthesiologists (ASA) physical status I and II
* scheduled to undergo elective Transurethral resection of the bladder tumor (TURB)

Exclusion Criteria:

* history of neuromuscular, renal, or hepatic disease
* a body mass index (BMI) of \< 18.5 or \> C 30.0 kg/m2
* treatment with drugs known to interfere with neuromuscular function

Primary outcomes:
measure: Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
timeFrame: immediately following the operation, an average of 5 minutes
Secondary outcomes:
measure: Incidence of Postoperative Residual Curarization
timeFrame: at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes
measure: Recovery Time (PACU Discharge)
timeFrame: During PACU stay (An average of 15 minutes)
measure: the Incidence of Desaturation
timeFrame: During PACU stay (An average of 15 minutes)
measure: Other Postoperative Adverse Events
timeFrame: During PACU stay (An average of 15 minutes)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Junghee Ryu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. World J Surg. 2016 Dec;40(12):2898-2903. doi: 10.1007/s00268-016-3633-8.
citation: Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.
citation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.