Laparoscopic Cholecystectomy, Neostigmine, Neuromuscular Blockade, Neuromuscular Blocking Agents, Physiological Effects of Drugs, Sugammadex, Urinary Retention Postoperative
Conditions
Brief 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.
Detailed description
Objective: To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic cholecystectomy. Hypothesis: Subjects who are reversed with sugammadex will have less postoperative urinary retention compared to subjects who are reversed with neostigmine.
Interventions
DRUGNeostigmine
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
DRUGSugammadex
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Blinded
Intervention model description
Single site, randomized, controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-80 years old * Undergoing laparoscopic cholecystectomy * Anticipated surgical duration \<2 hours * ASA physical status classification 1-3 * Willing and able to consent in English or Spanish * No personal history of neuromuscular disease
Exclusion criteria
* Preoperative urinary catheter * History of problems with urination * Current use of anticholinergic medications (e.g., antihistamines, phenothiazines, antidepressants, antipsychotics) * Current UTI or urogenital problem (incontinence, known bladder retention, prostate hypertrophy) * Planned intraoperative insertion of a urinary catheter * ESRD (GRF \<30 mL/min) * ESLD (AST or ALT \> 3x reference range) * Planned postoperative intubation/ventilation or admission to ICU * Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium * Pregnant or nursing women * Stat (emergent) cases * Known or suspected neurological condition (e.g., Alzheimer's, h/o of stroke, multiple sclerosis, Parkinson's) * Patients on toremifene (a selective estrogen receptor modulator) * Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups | In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge. | Measure pre- and post-void bladder volumes, void volume, and the time to void after operation. The count of participants with Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups is being reported. POUR will be defined as: 1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL 2. Postvoid residual \> 150 mL 3. Need for insertion of Foley catheter or straight catheter |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neostigmine One type of Neuromuscular Blockade Reversal Drug
Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. | 112 |
| Sugammadex One type of Neuromuscular Blockade Reversal Drug
Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex | 118 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Operation Cancelled | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Received Neostigmine + Sugammadex | 2 | 0 |
Baseline characteristics
| Characteristic | Neostigmine | Sugammadex | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 12 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants | 106 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 103 Participants | 99 Participants | 202 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 19 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 112 participants | 118 participants | 230 participants |
| Sex: Female, Male Female | 87 Participants | 89 Participants | 176 Participants |
| Sex: Female, Male Male | 25 Participants | 29 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 118 |
| other Total, other adverse events | 0 / 112 | 0 / 118 |
| serious Total, serious adverse events | 0 / 112 | 0 / 118 |
Outcome results
Primary
Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups
Measure pre- and post-void bladder volumes, void volume, and the time to void after operation. The count of participants with Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups is being reported. POUR will be defined as: 1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL 2. Postvoid residual \> 150 mL 3. Need for insertion of Foley catheter or straight catheter
Time frame: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neostigmine | Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups | 20 Participants |
| Sugammadex | Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups | 6 Participants |