NCT02728726

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 14, 2022

Completed
Last Updated

July 14, 2022

Status Verified

June 1, 2022

Enrollment Period

3.5 years

First QC Date

March 15, 2016

Results QC Date

May 25, 2022

Last Update Submit

June 21, 2022

Conditions

General Surgery

Keywords

Postoperative respiratory depressionNeuromuscular Agents

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Train of Four (TOF) Ratio

    upon PACU discharge, approximately 8 hours

Study Arms (2)

Sugammadex

EXPERIMENTAL

Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated.

Drug: Sugammadex

Placebo

PLACEBO COMPARATOR

Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated.

Drug: Placebo

Interventions

SugammadexDRUG

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

Also known as: Bridion
Sugammadex
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

The University of Texas, UTHealth

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
J. Ross Renew, M.D.
Organization
Mayo Clinic
Renew.J@mayo.edu
904-956-3328

Study Officials

  • J Ross Renew, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 5, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 14, 2022

Results First Posted

July 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)