Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT) (CRoSSECT)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Neuromuscular Blockade

Treatments: Drug: Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;; Drug: Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03532178

MISP#56343

Details and patient eligibility

About

The investigators propose to compare the recovery of neuromuscular blockade from rocuronium reversal by sugammadex to succinylcholine in ECT.

Full description

The proposed study is a single center, randomized, double-blind (patients, psychiatrists and outcome assessor), cross-over clinical trial comparing the recovery of neuromuscular blockade from rocuronium with reversal of sugammadex to succinylcholine in participants receiving ECT. The primary outcome will be the measurement of time when the first train-of-four (TOF) twitch (T1) returns to 90% of baseline. The secondary aims are to document the safety (adverse event rates) of rocuronium/sugammadex compared to succinylcholine in ECT patients. The exploratory aims are to establish the perioperative efficacy and efficiency of sugammadex reversal of rocuronium in ECT procedures in comparison with succinylcholine.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible and scheduled for ECT
• Has the capacity to consent for the study

Exclusion criteria

• Any acute major organ failure in the last 30 days
• Any known or suspected neuromuscular disorders
• Any history of allergic reaction or intolerance to sugammadex, rocuronium, or succinylcholine
• Any conditions with severe renal impairment, including those requiring dialysis
• Anyone currently taking lithium
• Anyone currently taking hormonal contraceptives
• Anyone taking anti-coagulants, including vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

44 participants in 2 patient groups

Group A

Experimental group

Description:

rocuronium + sugammadex / succinylcholine + normal saline

Treatment:

Drug: Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline

Group B

Experimental group

Description:

succinylcholine + normal saline / rocuronium + sugammadex

Treatment:

Drug: Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;