Neuromuscular Blockade on Shoulder Pain of Elderly

Malignant Neoplasms of Female Genital Organs Clinical Trial

Official title:

The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210376
• Other study ID #: 2017-0046
• Secondary ID: NCI-2018-01176
• Status: Completed
• Phase: Phase 4
• Start date: November 17, 2017
• Est. completion date: October 22, 2020

Study information

• Verified date: November 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups before your surgery. This is done because no one knows if one group is better, the same, or worse than the other.

• In Group 1, you will receive deep NMB and Sugammadex.

• In Group 2, you will receive moderate NMB and neostigmine.

Neither you nor the surgeon or surgical staff will know to which group you have been assigned. The surgeon will not know which group you are in because researchers want to learn how much, if at all, the surgeon needs to adjust the insufflation pressure during surgery. However, if needed for your safety, the surgeon will be able to find out which group you are in.

For your safety, the anesthesiologist will know to which group you have been assigned.

Surgery and Study Drug Administration:

After you have been assigned to a study group, you will have your surgery as scheduled. You will sign a separate consent form for surgery which describes the procedure and its risks in more detail. You will also sign a separate consent form to receive anesthesia.

Before your surgery, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to the status of the disease and/or your reaction to the study drug(s).

During the surgery, the insufflation pressure that is being used, including any changes that are made to the pressure, will be recorded. After the surgery has been completed, you will receive either Sugammadex or neostigmine by vein until the effects of the NMB have been reversed.

You will recover after surgery in the post-anesthesia care unit (PACU). At about 15, 45, and 90 minutes after your surgery, a PACU nurse will ask you about any shoulder pain you are feeling and if so, how intense the pain is. Information about how long you stay in the hospital after surgery and if you have any side effects after surgery (such as nausea/vomiting or shoulder pain) will also be collected from your medical record.

Follow-Up:

After 30 days after you leave the hospital, you will be called by a member of the study staff to ask how you are doing and if you have had any additional hospitalizations since leaving the hospital. This phone call should last about 5-10 minutes.

Length of Study Participation:

Your participation in this study will be over after completing the 30-day follow up phone call.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 22, 2020
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Patients 65 years of age or older

2. Patients having robotic prostatectomy

3. Written informed consent

Exclusion Criteria:

1. Patient with known hypersensitivity to Rocuronium, Sugammadex or its components

2. Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.

3. 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.

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Genital Neoplasms, Male
• Malignant Neoplasms of Digestive Organs
• Malignant Neoplasms of Female Genital Organs
• Malignant Neoplasms of Male Genital Organs
• Malignant Neoplasms of Urinary Tract
• Neoplasms
• Shoulder Pain
• Urologic Neoplasms

Intervention

Drug:
• Deep Neuromuscular Blockade (NMB)
Deep Neuromuscular Blockade (NMB) given during surgery.
• Moderate Neuromuscular Blockade (NMB)
Moderate Neuromuscular Blockade (NMB) given during surgery.
• Sugammadex
4 mg/Kg, intravenously as a single bolus injection after surgery.
• 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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative Intraoperative Insufflation Pressure	Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation.	Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)
Secondary	Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation	The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery. Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus.	Day 0 - Arrival time at PACU, an average of 3 minutes
Secondary	Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)	Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is<4 and no single category has a score of >1.Sedation.0:Patient is fully awake.1: Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate>10. 1: Snoring,10< RR<30. 2:R<10 or RR>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 = 94%.1:90%=SpO2<94%. 2:85%= SpO2 < 90%.3:SpO2 < 85%. Systolic Blood Pressure. 0:SBP = 100mmHg.1:90mmHg=SBP< 100mmHg.2:80mmHg=SBP< 90mmHg or SBP>220mmHg.3:SBP<80mmHg.Heart Rate.0:50	Assessed at 15, 45, 90 minutes during PACU stay.
Secondary	Percentage of Participants With Nausea and/or Vomiting in PACU	Degree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU).	Day 0 - PACU stay, an average of 120 minutes
Secondary	Surgical Exposure Grading		Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)
Secondary	Length of Hospital Stay		length of hospital stay(average of 3 days)

External Links

•   University of Texas MD Anderson Cancer Center Website