Neuromuscular Blockade During Transurethral Resection of Bladder Cancer

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: Sugammadex; Drug: Rocuronium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03039543

B-1701-378-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

moderate neuromuscular blockade

Active Comparator group

Description:

During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.

Treatment:

Drug: Rocuronium

Drug: Sugammadex

deep neuromuscular blockade

Experimental group

Description:

During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.

Treatment:

Drug: Rocuronium

Drug: Sugammadex