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Neuromuscular Blockade During Transurethral Resection of Bladder Cancer

Primary Purpose

Neuromuscular Blockade

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rocuronium
Sugammadex
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuromuscular Blockade

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

moderate neuromuscular blockade

deep neuromuscular blockade

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
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 Outcome Measures

Incidence of Postoperative Residual Curarization
the number of participant with Postoperative residual curarization (PORC, TOF ratio < 0.9 )
Recovery Time (PACU Discharge)
time needed to reach a modified Aldrete score of 9
the Incidence of Desaturation
Respiratory complication such as desaturation (SpO2 < 90%) were recorded during PACU stay.
Other Postoperative Adverse Events
Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort

Full Information

First Posted
January 25, 2017
Last Updated
April 23, 2018
Sponsor
Seoul National University Bundang Hospital
Collaborators
MSD Korea Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03039543
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
MSD Korea Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
moderate neuromuscular blockade
Arm Type
Active Comparator
Arm 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.
Arm Title
deep neuromuscular blockade
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Esmeron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
Description
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.
Time Frame
immediately following the operation, an average of 5 minutes
Secondary Outcome Measure Information:
Title
Incidence of Postoperative Residual Curarization
Description
the number of participant with Postoperative residual curarization (PORC, TOF ratio < 0.9 )
Time Frame
at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes
Title
Recovery Time (PACU Discharge)
Description
time needed to reach a modified Aldrete score of 9
Time Frame
During PACU stay (An average of 15 minutes)
Title
the Incidence of Desaturation
Description
Respiratory complication such as desaturation (SpO2 < 90%) were recorded during PACU stay.
Time Frame
During PACU stay (An average of 15 minutes)
Title
Other Postoperative Adverse Events
Description
Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort
Time Frame
During PACU stay (An average of 15 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junghee Ryu, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27405749
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.
Results Reference
result
PubMed Identifier
17307778
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.
Results Reference
result
PubMed Identifier
24240315
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.
Results Reference
result

Learn more about this trial

Neuromuscular Blockade During Transurethral Resection of Bladder Cancer

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