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Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block

Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block by Neostigmine or Sugammadex: A Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05545280
Enrollment
50
Registered
2022-09-19
Start date
2023-12-01
Completion date
2024-08-07
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Brief summary

The investigators propose a randomized trial comparing sugammadex and neostigmine for the reversal of neuromuscular blocks induced by rocuronium or vecuronium in adults having general anesthesia with muscular block for noncardiac surgery.

Detailed description

All patients will be asked to void before they are transferred to the operating room. Patients will be seen shortly before anesthetic induction (baseline, Visit 1). As this is a pragmatic trial, no restrictions to anesthetic management other than the random allocation to sugammadex or neostigmine are planned. As part of local standards, it is recommended to maintain a moderate block of 1 to 2 twitch responses to train-of-four (TOF) stimulation throughout surgery. Randomized treatments will be implemented by clinicians in collaboration with research personnel. Patients will be randomized shortly before the reversal of the neuromuscular block. At the time of randomization, the administration of either neostigmine or sugammadex need to be possible. If e.g. the neuromuscular block is too deep to be reversed with neostigmine, patients will not be randomized and excluded from the study. The anesthesiologist in charge will be informed on the patient's allocation to either the sugammadex or neostigmine group by an unblinded investigator. Patients will be monitored for twitch responses towards the end of surgery to determine the timing and dose for the reversal agent. The twitch response will be measured using a quantitative, acceleromyographic monitoring device. For sugammadex, 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to (TOF) stimulation. Alternatively, 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation. In the neostigmine group, neostigmine 2.5 mg with glycopyrrolate 0.5 mg will be administered as an initial dose. Neostigmine and glycopyrrolate are to be administered in a fixed ratio, and only if the second twitch in response to TOF stimulation has appeared. The initial dose can be repeated up to a ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate. However, the final decision of the dose will be up to the attending anesthesiologist. The administered dose will be recorded. All patients are required to have a documented TOF ratio \> 0.9 before extubation Visit 2 is one hour after surgery in the post anesthesia care unit (PACU). The third Visit is within 4 to 6 hours after surgery on the regular ward. Visit 4 and 5 will be in the morning and afternoon of the first day after surgery (postoperative day (POD) 1). Visit 5 on the afternoon of POD 1 will be the last follow-up and the end of a patient's participation in the study. Thereafter, data will be recorded from electronical medical records until POD 4 or discharge, whichever comes first.

Interventions

DRUGNeostigmine with glycopyrrolate

Administration by intravenous infusion

DRUGSugammadex

Administration by intravenous infusion

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Informed Consent as documented by signature; * Adults having noncardiac surgery with expected surgery duration ≥ 2 hours; * General anesthesia requiring endotracheal intubation and neuromuscular block with rocuronium or vecuronium; * Planned administration of sugammadex or neostigmine for reversal of the neuromuscular block at the end of surgery; * American Society of Anesthesiologists (ASA) physical status 1-3; * Age ≥ 65 years.

Exclusion criteria

* Contraindications to the class of drugs under study; * Preoperative urinary catheter; * Planned intraoperative insertion of a urinary catheter; * Neurosurgery (except spine surgery), intraabdominal or retroperitoneal surgeries including but not limited to any kind of laparoscopies, or surgeries in kidneys, ureters or urine bladder. * Planned postoperative admission to the ICU; * Severe preoperative hepatic impairment (≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range) or renal impairment (estimated GFR \< 30 ml/min or end-stage renal disease requiring scheduled dialysis.); * History of bladder cancer; * Presence of a sacral nerve stimulator; * Current use of anticholinergic medications such as antihistamines, phenothiazines, antidepressants or antipsychotics; * Urinary tract infections or other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which promote urinary retention; * Known or suspected neurological conditions such as Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, or Parkinson's disease.

Design outcomes

Primary

MeasureTime frameDescription
Urine Residual in PACU1 hour after surgery, which started from out of operation roomThe primary outcome of urinary retention is assessed by post-void bladder volume.

Secondary

MeasureTime frameDescription
Number of Participants Who Needed a Urinary Catheterwithin 24 hours after out of operation roomparticipants who needed a urinary catheter within 24 hours after surgery

Other

MeasureTime frameDescription
Participants Having Urinary Tract Infectionsduring postoperative hospital stay, which from out of operation room to discharge from the hospital, an average of 1 weekpatients having urinary tract infections during the hospitalization

Countries

United States

Participant flow

Participants by arm

ArmCount
Neostigmine
Reversal of Neuromuscular Block by Neostigmine. Neostigmine with glycopyrrolate: Administration by intravenous infusion
23
Sugammadex
Reversal of Neuromuscular Block by Sugammadex. Sugammadex: Administration by intravenous infusion
27
Total50

Baseline characteristics

CharacteristicNeostigmineTotalSugammadex
Age, Continuous72.1 years
STANDARD_DEVIATION 4.7
72.1 years
STANDARD_DEVIATION 5
72.1 years
STANDARD_DEVIATION 7
ASA score
1
1 Participants2 Participants1 Participants
ASA score
2
3 Participants5 Participants2 Participants
ASA score
3
18 Participants42 Participants24 Participants
ASA score
unknown
1 Participants1 Participants0 Participants
BMI26.1 kg/m227 kg/m228.6 kg/m2
cardiac disease16 Participants31 Participants15 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants46 Participants25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
kidney disease2 Participants5 Participants3 Participants
Metabolic equivalent
2.0
1 Participants1 Participants0 Participants
Metabolic equivalent
3.0
1 Participants2 Participants1 Participants
Metabolic equivalent
3.5
1 Participants2 Participants1 Participants
Metabolic equivalent
>4
10 Participants24 Participants14 Participants
Metabolic equivalent
4.0
10 Participants21 Participants11 Participants
neurological disease10 Participants19 Participants9 Participants
previous surgery22 Participants47 Participants25 Participants
pulmonary disease6 Participants16 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
22 Participants48 Participants26 Participants
Sex: Female, Male
Female
10 Participants19 Participants9 Participants
Sex: Female, Male
Male
13 Participants31 Participants18 Participants
Substance abuse -alcohol abuse0 Participants2 Participants2 Participants
Substance abuse-illegal drug use0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 27
other
Total, other adverse events
0 / 230 / 27
serious
Total, serious adverse events
0 / 230 / 27

Outcome results

Primary

Urine Residual in PACU

The primary outcome of urinary retention is assessed by post-void bladder volume.

Time frame: 1 hour after surgery, which started from out of operation room

Population: A total of 50 patients were included in data analysis based on the modified intent-to-treat rule

ArmMeasureValue (MEDIAN)
NeostigmineUrine Residual in PACU219 ml
SugammadexUrine Residual in PACU222 ml
Secondary

Number of Participants Who Needed a Urinary Catheter

participants who needed a urinary catheter within 24 hours after surgery

Time frame: within 24 hours after out of operation room

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NeostigmineNumber of Participants Who Needed a Urinary Catheter5 Participants
SugammadexNumber of Participants Who Needed a Urinary Catheter2 Participants
Other Pre-specified

Participants Having Urinary Tract Infections

patients having urinary tract infections during the hospitalization

Time frame: during postoperative hospital stay, which from out of operation room to discharge from the hospital, an average of 1 week

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NeostigmineParticipants Having Urinary Tract Infections0 Participants
SugammadexParticipants Having Urinary Tract Infections0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026