Does Depth of Neuromuscular Blockade (NMB) Affect Surgical Conditions in Obese Patients Undergoing Robotic Surgery

NCT03591289 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 17.1119
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized, outcome trial to evaluate, if depth of neuromuscular blockade (NMB) will affect surgical conditions and postoperative pain based on the degree of neuromuscular block during robotic surgery for gynecological and urologic procedures in obese and non-obese patients.

Conditions

GYN Disorders; Urologic Diseases

Keywords

Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• Assessment of surgical conditions during deep versus moderate NMB in patients undergoing robotic abdominal surgery

  Surgical conditions will be assessed by the Leiden surgical rating scale (Martini BJA 2014; 112:498) as follows: Scale range from 1 to 5 with 1 describing extremely poor conditions and 5 describing optimal conditions for surgery

  data will be reported every 15 minutes starting post anesthesia induction until the end of general anesthesia

Secondary Outcomes (3)

• Assessment of PVI changes to predict fluid responsiveness in robotic surgery

  PVI will be measured every 15 minutes and after any fluid bolus. Fluid bolus will be given, when PVI is > 12

• Incidence of good and optimal surgical conditions in obese and non-obese patients undergoing robotic abdominal surgery

  Data will be reported every 15 minutes starting post anesthesia induction until the end of general anesthesia

• Assessment of postoperative pain after deep versus moderate NMB in patients undergoing robotic abdominal surgery. Does depth of neuromuscular block (NMB) affect postoperative pain ?

  First 24 hours postoperatively at time points 1hour, 6 hours after surgery and postoperative day one

Study Arms (2)

Deep NMB

ACTIVE COMPARATOR

Deep NMB: Intervention: Rocuronium will be given as a continuous infusion for deep block. TOF will be maintained at 0 (zero) with at least one PTC. Patients' paralysis will be continued through the anesthesia period. At the end of surgery, patients will receive 4 mg/kg sugammadex and the patient's trachea will be extubated according to routine extubation criteria.

Drug: NMB with rocuronium bromide

Moderate NMB

ACTIVE COMPARATOR

Moderate NMB: Intervention: Rocuronium will be used as bolus doses to achieve a moderate block. TOF will be maintained between 1 to 3 twitches. PTC will not be counted. Paralysis will be continued throughout the anesthesia period. At the end of surgery, patients will receive 2 mg/kg sugammadex and the patient's trachea will be extubated according to routine extubation criteria.

Drug: NMB with rocuronium bromide

Interventions

NMB with rocuronium bromide DRUG

Moderate versus deep neuromuscular block Not a device study

Also known as: Reversal with suggammadex

Deep NMB; Moderate NMB

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for elective robotic gynecological or urologic surgery under general anesthesia.
• Patients are willing and sign an IRB approved consent
• Patients will be 18 years or older

You may not qualify if:

• Patients with atrial fibrillation
• Other significant arrhythmia (Lown grade 3 or greater)
• Patients with aortic regurgitation
• Unable to receive or refuses to usehydromorphone for pain management post-operatively (allergic, bad experience previously with use)

Sponsors & Collaborators

• Rainer Lenhardt: lead

Study Sites (1)

University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Genital Diseases, Female; Urologic Diseases

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Elizabeth Cooke, RN,BSN, CCRP

  University of Louisville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will not be informed to which NMB depth they were randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Vice-Chair Clinical Affairs; Department of Anesthesiology and Perioperative Medicine, MBA

Model Details: two different regimens (doses) of two drugs (Rocuronium, Sugammadex)

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: July 19, 2018
• Study Start: February 1, 2018
• Primary Completion: February 1, 2018
• Study Completion: July 12, 2018
• Last Updated: July 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)