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Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

NCT03944473 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-11-18

No results posted yet for this study

Summary

In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.

The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.

Conditions

  • Ambulatory Difficulty

Interventions

DRUG

Sugammadex

Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent

DRUG

Neostigmine

Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Curtis Choice, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2020-07-20
Completion
2020-07-20
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944473 on ClinicalTrials.gov