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NCT Number: NCT03039543

Neuromuscular Blockade During Transurethral Resection of Bladder Cancer

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.

Other names: Esmeron

Sugammadex

Drug

Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.

Other names: Bridion

Primary outcomes

  1. Number of Participants Attaining a 5 (Optimal) Surgical Condition Score

    Time frame: immediately following the operation, an average of 5 minutes

    5-point surgical condition scale was evaluated as follows.

    • Extremely poor
    • unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.
    • Poor
    • severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.
    • Acceptable
    • a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration.
    • Good
    • a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.
    • Optimal
    • a wide endoscopic working field without any movement or contractions. No additional NMB is needed.

Secondary outcomes

  1. Incidence of Postoperative Residual Curarization

    Time frame: at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes

    the number of participant with Postoperative residual curarization (PORC, TOF ratio < 0.9 )

  2. Recovery Time (PACU Discharge)

    Time frame: During PACU stay (An average of 15 minutes)

    time needed to reach a modified Aldrete score of 9

  3. the Incidence of Desaturation

    Time frame: During PACU stay (An average of 15 minutes)

    Respiratory complication such as desaturation (SpO2 < 90%) were recorded during PACU stay.

  4. Other Postoperative Adverse Events

    Time frame: During PACU stay (An average of 15 minutes)

    Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • MSD Korea Ltd.

Registry information

Official study title

The Effect of Neuromuscular Blockade During Transurethral Resection of Bladder Cancer on Surgical Condition and Recovery Profiles : A Prospective, Randomized and Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2017
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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