Trial Outcomes & Findings for Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery (NCT NCT03923556)

NCT ID: NCT03923556

Last Updated: 2025-05-22

Results Overview

Presence of one or more episodes of hypoventilation in PACU, adjusted to qTOF and other confounders

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 84 participants
• Primary outcome timeframe: Within up to 3 hours after the end of surgery
• Results posted on: 2025-05-22

Participant Flow

Participant milestones

Measure	Sugammadex Sugammadex 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 Neostigmine 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
Overall Study STARTED	42	42
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sugammadex n=42 Participants Sugammadex 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 n=42 Participants Neostigmine 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	Total n=84 Participants Total of all reporting groups
Age, Continuous	48 years n=93 Participants	53 years n=4 Participants	50 years n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	21 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	21 Participants n=4 Participants	52 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	30 Participants n=93 Participants	26 Participants n=4 Participants	56 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	9 Participants n=93 Participants	7 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	3 Participants n=93 Participants	9 Participants n=4 Participants	12 Participants n=27 Participants
Preoperative hemodialysis	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants

PRIMARY outcome

Timeframe: Within up to 3 hours after the end of surgery

Presence of one or more episodes of hypoventilation in PACU, adjusted to qTOF and other confounders

Outcome measures

Measure	Sugammadex n=40 Participants Sugammadex 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 n=40 Participants Neostigmine 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
Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)	22 Participants	23 Participants

SECONDARY outcome

Timeframe: Within up to 3 hours after the end of surgery

Incidence of qTOF <0.9 in PACU

Outcome measures

Measure	Sugammadex n=42 Participants Sugammadex 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 n=42 Participants Neostigmine 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
Number of Patients With Presence of qTOF <0.9 in PACU	13 Participants	25 Participants

SECONDARY outcome

Timeframe: Within up to 3 postoperative days and at 14 +/- 3 days after surgery

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.

Outcome measures

Measure	Sugammadex n=42 Participants Sugammadex 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 n=42 Participants Neostigmine 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
Number of Participants With Kidney Graft Dysfunction	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Within up to 3 postoperative days

Adverse events related to NMBR medications, including hypersensitivity and any other adverse events

Outcome measures

Measure	Sugammadex n=42 Participants Sugammadex 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 n=42 Participants Neostigmine 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
Rate of Adverse Events Related to NMBR Medications	0 Participants	0 Participants

Adverse Events

Sugammadex

Serious events: 4 serious events

Other events: 2 other events

Deaths: 0 deaths

Neostigmine

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sugammadex n=42 participants at risk Sugammadex 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 n=42 participants at risk Neostigmine 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
Renal and urinary disorders Postoperative ureteral leak	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.	0.00% 0/42 • First 2 postoperative weeks Following definitions and processes described in protocol.
Vascular disorders Cerebrovascular accident	0.00% 0/42 • First 2 postoperative weeks Following definitions and processes described in protocol.	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.
Vascular disorders Reoperation for bleeding	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.
Renal and urinary disorders Kidney graft dysfunction	4.8% 2/42 • First 2 postoperative weeks Following definitions and processes described in protocol.	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.
Respiratory, thoracic and mediastinal disorders Opioid-induced respiratory depression	0.00% 0/42 • First 2 postoperative weeks Following definitions and processes described in protocol.	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.

Other adverse events

Measure	Sugammadex n=42 participants at risk Sugammadex 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 n=42 participants at risk Neostigmine 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
Respiratory, thoracic and mediastinal disorders Respiratory symptoms requiring oxygen supplementation	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.
Infections and infestations Urinary tract infection	2.4% 1/42 • First 2 postoperative weeks Following definitions and processes described in protocol.	0.00% 0/42 • First 2 postoperative weeks Following definitions and processes described in protocol.

Additional Information

Dr. Ana Fernandez-Bustamante

University of Colorado School of Medicine

Phone: 720-848-6744

Email: ana.fernandez-bustamante@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place