Comparing Sugammadex and Neostigmine in PACU Recovery

This study is comparing two medications, Sugammadex and Neostigmine, which are used to reverse the effects of muscle relaxants given during surgery. Researchers want to see if one medication helps patients recover faster in the Post Anesthesia Care Unit (PACU) after abdominal surgeries like hernia or gallbladder repair. They will measure how long you stay in the PACU, your pain levels using a Visual Analog Scale (VAS), and your recovery score (Aldrete Score) for up to six months after surgery. You may be able to join if you are between 18 and 75 years old, having certain abdominal surgeries lasting 90-120 minutes, and meet other health criteria. The current status of the study is unclear.

Study design
This is a prospective, randomized study that plans to enroll 50 participants to compare the two medications.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your recovery will be monitored for up to six months after surgery, including PACU stay length, pain scores, and Aldrete scores.

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NCT04096144

Comparison of Sugammadex and Neostigmine During PACU Stay

Not Yet Recruiting
PHASE3Ages 18–65Interventional
University of South Florida
~50 participants
Updated 2019-09-19 on ClinicalTrials.gov
What's tested:Neuromuscular Blocking Agents

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Length of Post Anesthesia Care Unit (PACU) stay
Measured over 6 months
+4 more outcomes measured
Neuromuscular Blockade
1 sites across 1 states
Florida1
  • Enrico M Camporesi, MD · PRINCIPAL_INVESTIGATOR · TEAMHealth Anesthesia/Tampa General Hospital
  • Maha Balouch, MA · STUDY_CHAIR · TEAMHealth Anesthesia/Tampa General Hospital
  • Michael Albrink, MD · PRINCIPAL_INVESTIGATOR · Tampa General Hospital

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Eligibility criteria

Inclusion

18-75 years of age
Patients with surgeries with duration of 90-120 minutes
ASA Patients I-III (Appendix A)
Patients admitted to TGH for abdominal hernia repair, cholecystectomy and/or abdominal surgery as performed by Dr. Albrink
BMI \> 30

Exclusion

\<18 years of age
ASA Patients IV and above (Appendix A)
Patients with allergic reactions to Neostigmine+Glycopyrrolate and/or Sugammadex
  • Length of Post Anesthesia Care Unit (PACU) stay6 months

    Time spent in the recovery room (PACU).

  • Pain (Visual Analog Scale) VAS scores6 months

    Evaluation of the level of pain

  • Aldrete Score6 months

    Evaluation of level of alertness of the patient at the conclusion of PACU stay for discharge.

  • Pulse Oximetry6 months

    Finger Saturation

  • Blood Pressure upon PACU discharge6 months

    Evaluation of Blood Pressure at the conclusion of PACU stay.