Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery

Kidney Transplant; Complications Clinical Trial

Official title:

A Double-blind, Randomized, Parallel Study to Compare the Efficacy of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery in Patients With Severe Kidney Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03923556
• Other study ID #: 18-2707
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: Ana Fernandez-Bustamante, M.D., Ph.D.
• Phone: 303-724-2935
• Email: ana.fernandez-bustamante[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two medications that reverse muscle paralysis at the end of kidney transplant surgery with the goal of reducing residual muscle weakness and insufficient respiratory function after surgery.

Description:

This is a prospective randomized double-blind single center study on patients with severe kidney failure undergoing kidney transplantation surgery. Patients will have their muscles paralyzed during general anesthesia for surgery. At the end of surgery, muscle paralysis will be reversed with either neostigmine (control group) or sugammadex (intervention group). Residual muscle weakness and respiratory function will be monitored after surgery with a quantitative train-of-four (qTOF) monitor and a noninvasive continuous ventilation monitor. The investigators hypothesize that patients receiving sugammadex will have less residual muscle weakness and better respiratory function than patients receiving neostigmine. Respiratory and kidney function parameters and any adverse events will be collected during the hospital stay. Patients will contacted for a study follow up around 2 weeks after their surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• At least 18 years or older

• Diagnosed with severe kidney dysfunction (defined by plasma creatinine clearance <30 mL/min)

• Planning on kidney transplantation surgery at the University of Colorado Hospital.

Exclusion Criteria:

• Patients unable to sign the informed consent

• Pregnant women

• Body Mass Index (BMI) > 40 kg/m2

• Pre-existing oxygen or ventilatory dependency (24h use of oxygen or other noninvasive or invasive ventilatory support)

• Patients with any pulmonary, neuromuscular or other disease that severely limits their respiratory functional status (e.g. unable to achieve 4 Metabolic Equivalent of Tasks, METs, such as climbing up 1 flight of stairs)

• Presence of any contraindication for any of the study-related medications or interventions.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Kidney Transplant; Complications
• Postoperative Residual Curarization
• Postoperative Residual Weakness

Intervention

Drug:
• Sugammadex
Administration of Sugammadex intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 2-4 mg/kg) at the end of the surgery before tracheal extubation
• Neostigmine
Administration of Neostigmine intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 0.03-0.07 mg/kg) at the end of the surgery before tracheal extubation

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoventilation in post-anesthesia care unit (PACU)	Presence of one or more episodes of hypoventilation in PACU, adjusted to qTOF and other confounders	Within up to 3 hours after the end of surgery
Secondary	Time from NMBR administration to adequate NMBR	Intraoperative minutes from NMBR administration to qTOF T4/T1 equal or greater than 0.9	Within minutes from NMBR administration intraoperatively
Secondary	Time from NMBR administration to tracheal extubation	Intraoperative minutes from NMBR administration to tracheal extubation	Within minutes from NMBR administration intraoperatively
Secondary	Duration of surgery	Intraoperative minutes from surgical incision to closure (duration of surgery)	During operating room stay
Secondary	Duration of anesthesia	Intraoperative minutes from tracheal intubation to tracheal extubation (duration of anesthesia)	During operating room stay
Secondary	Presence of qTOF <0.9 in PACU	Incidence of qTOF <0.9 in PACU	Within up to 3 hours after the end of surgery
Secondary	Number of events of hypoventilation in PACU	Number of events of hypoventilation lasting 1 minute or longer in PACU	Within up to 3 hours after the end of surgery
Secondary	Accumulated minutes of hypoventilation in PACU	Accumulated minutes of hypoventilation in PACU	Within up to 3 hours after the end of surgery
Secondary	Delayed postoperative hypoventilation	Presence of one or more episodes of hypoventilation in postoperative floor, adjusted to qTOF and other confounders	Within up to 3 postoperative days, counting from PACU discharge
Secondary	Number of events of delayed postoperative hypoventilation	Number of events of hypoventilation lasting 1 minute or longer in the postoperative floor	Within up to 3 postoperative days, counting from PACU discharge
Secondary	Accumulated minutes of delayed postoperative hypoventilation	Accumulated minutes of hypoventilation in the postoperative floor	Within up to 3 postoperative days, counting from PACU discharge
Secondary	qTOF <0.9 in postoperative floor	Delayed detection of qTOF <0.9 in postoperative floor	Within up to 3 postoperative days, counting from PACU discharge
Secondary	Presence of postoperative pulmonary complications	Presence of predefined postoperative pulmonary complications, including respiratory failure, reintubation, ARDS, pneumonia, pneumothorax, atelectasis, pleural effusion or bronchospasm.	Within up to 3 postoperative days and at 14 +/- 3 days after surgery
Secondary	Dyspnea functional limitation	Score on standardized Patient-Reported Outcomes Measurement Information System (Promis) dyspnea functional limitation questionnaire score, compared to patient's baseline. Functional measurements include walking, lifting and activities of daily living. The higher the score on this instrument the more functional limitation (scale range is from 0 to 30)	Within up to 14 +/- 3 days after surgery
Secondary	Kidney graft function as measured by postoperative plasma clearance of creatinine (ClCr)	Predefined kidney graft function based on postoperative ClCr	Within up to 3 postoperative days and at 14 +/- 3 days after surgery
Secondary	Number of participants with kidney graft dysfunction	Predefined kidney graft negative outcomes including: postoperative increasing ClCr, reduced daily urine output, need for dialysis postoperatively, and/or diagnosis of delayed graft function or kidney graft rejection.	Within up to 3 postoperative days and at 14 +/- 3 days after surgery
Secondary	Rate of adverse events	Adverse events related to NMBR medications, including hypersensitivity and any other adverse events	Within up to 3 postoperative days
Secondary	Hospital resources utilization: total operating room time	Hospital resources utilization parameters, including total operating room time	During operating room stay
Secondary	Hospital resources utilization: PACU stay duration	Hospital resources utilization parameters, including total PACU stay duration	During PACU stay
Secondary	Hospital resources utilization: Hospital length of stay	Hospital resources utilization parameters, including total hospital stay duration	Within up to 14 +/- 3 days after surgery
Secondary	Hospital resources utilization: Rate of ICU admission	Hospital resources utilization parameters, including the need of ICU admission	Within up to 14 +/- 3 days after surgery
Secondary	Hospital resources utilization: ICU length of stay	Hospital resources utilization parameters, including total ICU stay duration	Within up to 14 +/- 3 days after surgery