Neuromuscular Blockade During Transurethral Resection of Bladder Cancer

NCT03039543 | Completed Phase 4 Results FDA Drug

• 1 other identifier: B-1701-378-006
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

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

  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.

  immediately following the operation, an average of 5 minutes

Secondary Outcomes (4)

• Incidence of Postoperative Residual Curarization

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

• Recovery Time (PACU Discharge)

  During PACU stay (An average of 15 minutes)

• the Incidence of Desaturation

  During PACU stay (An average of 15 minutes)

• Other Postoperative Adverse Events

  During PACU stay (An average of 15 minutes)

Study Arms (2)

moderate neuromuscular blockade

ACTIVE COMPARATOR

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; Drug: Sugammadex

deep neuromuscular blockade

EXPERIMENTAL

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; Drug: Sugammadex

Interventions

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.

Also known as: Esmeron

deep neuromuscular blockade; moderate neuromuscular blockade

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.

Also known as: Bridion

deep neuromuscular blockade; moderate neuromuscular blockade

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• MSD Korea Ltd.: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (3)

• 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.

  PMID: 27405749 RESULT

• 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.

  PMID: 17307778 RESULT

• 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.

  PMID: 24240315 RESULT

MeSH Terms

Interventions

Rocuronium; Sugammadex

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Junghee Ryu, Associate Professor
• Organization: Seoul National University Bundang Hospital

jinaryu74@gmail.com

82-31-787-7497

Study Officials

• Junghee Ryu, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 1, 2017
• Study Start: June 1, 2017
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: May 22, 2018
• Results First Posted: May 22, 2018

Record last verified: 2018-04

Locations

KR (1)