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

NCT05794503 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2024-10-09

Study results available
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Summary

This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.

Conditions

  • Urinary Retention Postoperative
  • Laparoscopic Cholecystectomy
  • Neuromuscular Blockade
  • Sugammadex
  • Neostigmine
  • Neuromuscular Blocking Agents
  • Physiological Effects of Drugs

Interventions

DRUG

Neostigmine

Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.

DRUG

Sugammadex

Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Tiffany Moon, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05794503 on ClinicalTrials.gov