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Cholinesterase Inhibitor

Neostigmine vs Sugammadex for Postoperative Urinary Retention

Q: Is this trial open to senior citizens?

This study is open to those over 18 years old and younger than 80.

Q: Are researchers still enrolling participants in this trial?

This medical trial is continuing to actively recruit patients. According to clinicaltrials.gov, it was first made publicly available on September 1st 2023 and its information has been updated as recently as the 5th of September in that same year.

Q: What is the current enrollment rate of participants in this clinical trial?

Affirmative. According to clinicaltrials.gov, this medical study is still actively searching for participants; it was posted on September 1st 2023 and the most recent update happened on September 5th 2023. The trial hopes to recruit 230 individuals from one location.

Q: Who is the most appropriate demographic for this medical trial?

This trial requires 230 people between the ages of 18-80 with neostigmine to participate. To be eligible, they must also meet the criteria for ASA physical status classification 1-3, have an anticipated surgical duration under 2 hours, and demonstrate their willingness and capacity to consent in either English or Spanish; additionally there should not be a personal history of neuromuscular disease.

Phase < 1

Recruiting

Led By Tiffany Moon, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing laparoscopic cholecystectomy

ASA physical status classification 1-3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial will look at how well a drug (neostigmine or sugammadex) works to reverse the effects of a muscle-relaxing drug given during laparoscopic cholecystectomy.

Who is the study for?

This trial is for adults aged 18-80 undergoing laparoscopic cholecystectomy with an expected surgery time under 2 hours. They should be in relatively good health (ASA status 1-3) and not have neuromuscular diseases. Excluded are those needing post-op ICU, with neurological conditions, pregnant/nursing women not using non-hormonal contraception, UTI or urogenital issues, severe kidney/liver disease, allergies to study drugs, on anticholinergics or toremifene.Check my eligibility

What is being tested?

The study compares two drugs used after surgery to reverse muscle relaxation caused by rocuronium: Neostigmine and Sugammadex. It's a controlled trial where patients are randomly chosen to receive one of the two drugs following standard anesthesia protocol during their gallbladder removal surgery.See study design

What are the potential side effects?

Possible side effects from Neostigmine include slow heart rate, low blood pressure, nausea and vomiting. Sugammadex may cause allergic reactions, changes in heart rhythm or bleeding risk; however individual responses can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a laparoscopic surgery to remove my gallbladder.

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I am in good to moderate health with some medical problems.

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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence rates of postoperative urinary retention (POUR) of sugammadex and neostigmine groups.

Trial Design

2Treatment groups

Active Control

Group I: NeostigmineActive Control1 Intervention

One type of Neuromuscular Blockade Reversal Drug

Group II: SugammadexActive Control1 Intervention

One type of Neuromuscular Blockade Reversal Drug

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,505 Total Patients Enrolled

Tiffany Moon, MDPrincipal InvestigatorUT Southwestern Medical Center

8 Previous Clinical Trials

4,808 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to senior citizens?

"This study is open to those over 18 years old and younger than 80."

Answered by AI

Are researchers still enrolling participants in this trial?

"This medical trial is continuing to actively recruit patients. According to clinicaltrials.gov, it was first made publicly available on September 1st 2023 and its information has been updated as recently as the 5th of September in that same year."

Answered by AI

What is the current enrollment rate of participants in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical study is still actively searching for participants; it was posted on September 1st 2023 and the most recent update happened on September 5th 2023. The trial hopes to recruit 230 individuals from one location."

Answered by AI

Who is the most appropriate demographic for this medical trial?

"This trial requires 230 people between the ages of 18-80 with neostigmine to participate. To be eligible, they must also meet the criteria for ASA physical status classification 1-3, have an anticipated surgical duration under 2 hours, and demonstrate their willingness and capacity to consent in either English or Spanish; additionally there should not be a personal history of neuromuscular disease."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex

Tiffany B Moon 2023. "Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05794503.

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