Neuromuscular Blockade on Shoulder Pain of Elderly

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

Interventions

DRUG

Deep Neuromuscular Blockade (NMB)

Deep Neuromuscular Blockade (NMB) given during surgery.

DRUG

Moderate Neuromuscular Blockade (NMB)

Moderate Neuromuscular Blockade (NMB) given during surgery.

DRUG

Sugammadex

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

DRUG

Neostigmine

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

BEHAVIORAL

Pain Assessment

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Wendell H. Williams III, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-17

Primary Completion

2018-09-30

Completion

2020-10-22

FDA Drug

Yes

Countries

• United States

Study Locations