Neuromuscular Blockade on Shoulder Pain of Elderly

NCT03210376 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2017-0046NCI-2018-01176
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP. In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon. To reverse the effects of NMB after surgery, a drug called neostigmine is given. The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given. This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery. Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

Malignant Neoplasms of Digestive Organs; Malignant Neoplasms of Female Genital Organs; Malignant Neoplasms of Male Genital Organs; Malignant Neoplasms of Urinary Tract

Keywords

Malignant neoplasms of digestive organs; Malignant neoplasms of female genital organs; Malignant neoplasms of male genital organs; Malignant neoplasms of urinary tract; Neuromuscular blockade; NMB; Sugammadex; Neostigmine; Pain Assessment; Survey

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Reported Shoulder Pain

  Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.

  30 days

Secondary Outcomes (6)

• Cumulative Intraoperative Insufflation Pressure

  Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)

• Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation

  Day 0 - Arrival time at PACU, an average of 3 minutes

• Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)

  Assessed at 15, 45, 90 minutes during PACU stay.

• Percentage of Participants With Nausea and/or Vomiting in PACU

  Day 0 - PACU stay, an average of 120 minutes

• Surgical Exposure Grading

  Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)

Study Arms (2)

Deep Neuromuscular Blockade (NMB) + Sugammadex

EXPERIMENTAL

Deep Neuromuscular Blockade (NMB) given during surgery. Sugammadex intravenously as a single bolus injection after surgery. Pain assessment done at about 15, 45, and 90 minutes after surgery.

Drug: Deep Neuromuscular Blockade (NMB); Drug: Sugammadex; Behavioral: Pain Assessment

Moderate Neuromuscular Blockade (NMB) + Neostigmine

EXPERIMENTAL

Moderate Neuromuscular Blockade (NMB) given during surgery. Neostigmine intravenously slowly over a period of at least 1 minute after surgery. Pain assessment done at about 15, 45, and 90 minutes after surgery.

Drug: Moderate Neuromuscular Blockade (NMB); Drug: Neostigmine; Behavioral: Pain Assessment

Interventions

Deep Neuromuscular Blockade (NMB) DRUG

Deep Neuromuscular Blockade (NMB) given during surgery.

Deep Neuromuscular Blockade (NMB) + Sugammadex

Moderate Neuromuscular Blockade (NMB) DRUG

Moderate Neuromuscular Blockade (NMB) given during surgery.

Moderate Neuromuscular Blockade (NMB) + Neostigmine

Sugammadex DRUG

4 mg/Kg, intravenously as a single bolus injection after surgery.

Deep Neuromuscular Blockade (NMB) + Sugammadex

Neostigmine DRUG

70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.

Moderate Neuromuscular Blockade (NMB) + Neostigmine

Pain Assessment BEHAVIORAL

Pain assessment done at about 15, 45, and 90 minutes after surgery.

Also known as: Survey

Deep Neuromuscular Blockade (NMB) + Sugammadex; Moderate Neuromuscular Blockade (NMB) + Neostigmine

Eligibility Criteria

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

You may qualify if:

• Patients 65 years of age or older
• Patients having robotic prostatectomy
• Written informed consent

You may not qualify if:

• Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
• Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
• Patients with history of severe liver disease, defined as and confirmed by elevated ALT and AST greater than 1.5 times the Upper Limit of Normal along with Albumin less than 3 OR INR 1.5 or greater per institutional laboratory.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Williams WH 3rd, Cata JP, Lasala JD, Navai N, Feng L, Gottumukkala V. Effect of reversal of deep neuromuscular block with sugammadex or moderate block by neostigmine on shoulder pain in elderly patients undergoing robotic prostatectomy. Br J Anaesth. 2020 Feb;124(2):164-172. doi: 10.1016/j.bja.2019.09.043. Epub 2019 Nov 26.

  PMID: 31780139 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Urologic Neoplasms

Interventions

Sugammadex; Neostigmine; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Wendell H. Williams III / Anesthesiology & Perioperative Medicine
• Organization: UT MD Anderson Cancer Center

WHWilliams@mdanderson.org

713-563-0034

Study Officials

• Wendell H. Williams III, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 6, 2017
• Study Start: November 17, 2017
• Primary Completion: September 30, 2018
• Study Completion: October 22, 2020
• Last Updated: November 25, 2020
• Results First Posted: October 7, 2019

Record last verified: 2020-11

Locations

US (1)