Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

General Surgery Clinical Trial

Official title:

Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728726
• Other study ID #: 15-008685
• Status: Completed
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.

Other known NCT identifiers

• NCT02822001

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients undergoing surgery with general anesthesia
• Patients weighing > or = 80 pounds
• Patients not intubated prior to surgery
• Patients who are able to give informed consent

Exclusion Criteria:

• Patients unable to give informed consent.
• Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
• Patients who are anticipated to remain intubated in recovery period.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• General Surgery

Intervention

Drug:
• Sugammadex
Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
• Placebo
Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.

Locations

Country	Name	City	State
United States	The University of Texas, UTHealth	Houston	Texas
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	Merck Sharp & Dohme LLC, Respiratory Motion, Inc., University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased Minute Ventilation (MV)	The number of subjects who have a MV as defined as [MV <80% MV predicted (MVPRED) based on Body Surface Area]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.	15---30 minutes after Post-anesthesia care unit (PACU) arrival
Primary	Decreased Average Minute Ventilation (MV)	The number of subjects who have an average MV <80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.	15---30 minutes after Post-anesthesia care unit (PACU) arrival
Secondary	Train of Four (TOF) Ratio	The number of subjects to have a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)	upon PACU discharge, approximately 8 hours

External Links

•   Mayo Clinic Clinical Trials