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Neuromuscular Blockade During Transurethral Resection of Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03039543
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
MSD Korea Ltd.
Information provided by (Responsible Party):
Junghee Ryu, Seoul National University Bundang Hospital

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.


Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Rocuronium Drug: Sugammadex Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 10, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: moderate neuromuscular blockade
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.
Drug: Rocuronium
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 Name: Esmeron

Drug: Sugammadex
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 Name: Bridion

Experimental: deep neuromuscular blockade
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.
Drug: Rocuronium
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 Name: Esmeron

Drug: Sugammadex
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 Name: Bridion




Primary Outcome Measures :
  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.

    1. 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.
    2. Poor

      • severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.
    3. 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.
    4. 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.
    5. Optimal

      • a wide endoscopic working field without any movement or contractions. No additional NMB is needed.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039543


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Bundang Hospital
MSD Korea Ltd.
Investigators
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Principal Investigator: Junghee Ryu, MD, PhD Seoul National University Bundang Hospital
  Study Documents (Full-Text)

Documents provided by Junghee Ryu, Seoul National University Bundang Hospital:
Statistical Analysis Plan  [PDF] March 15, 2018
Study Protocol  [PDF] March 15, 2018


Publications of Results:
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Responsible Party: Junghee Ryu, Associate professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03039543    
Other Study ID Numbers: B-1701-378-006
First Posted: February 1, 2017    Key Record Dates
Results First Posted: May 22, 2018
Last Update Posted: May 22, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Rocuronium
Physiological Effects of Drugs
Peripheral Nervous System Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents