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

Neuromuscular Blockade Clinical Trial

— CRoSSECT  

Official title:

A Double-Blind, Randomized, Crossover Design Study To Compare The Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532178
• Other study ID #: MISP#56343
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 1, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline
The participants will be randomized to start with "Muscle relaxant #1" in the first study treatment, and will switch to "Muscle relaxant #2" in the second study treatment period.
• Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;
The participants will be randomized to start with "Muscle relaxant #2" in the first study treatment, and will switch to "Muscle relaxant #1" in the second study treatment period.

Locations

Country	Name	City	State
United States	UCSF Parnassus Campus	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (11)

Ali HH, Utting JE, Nightingale DA, Gray C. Quantitative assessment of residual curarization in humans. Br J Anaesth. 1970 Sep;42(9):802-3. No abstract available. — View Citation

Fink M. What was learned: studies by the consortium for research in ECT (CORE) 1997-2011. Acta Psychiatr Scand. 2014 Jun;129(6):417-26. doi: 10.1111/acps.12251. Epub 2014 Feb 12. — View Citation

Friedman S, Baker T, Gatti M, Simon G, Paskin S. Probable succinylcholine-induced rhabdomyolysis in a male athlete. Anesth Analg. 1995 Aug;81(2):422-3. doi: 10.1097/00000539-199508000-00040. No abstract available. — View Citation

Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology. 2005 Oct;103(4):695-703. doi: 10.1097/00000542-200510000-00007. — View Citation

Iwatsuki N, Kuroda N, Amaha K, Iwatsuki K. Succinylcholine-induced hyperkalemia in patients with ruptured cerebral aneurysms. Anesthesiology. 1980 Jul;53(1):64-7. doi: 10.1097/00000542-198007000-00013. No abstract available. — View Citation

Kadoi Y, Hoshi H, Nishida A, Saito S. Comparison of recovery times from rocuronium-induced muscle relaxation after reversal with three different doses of sugammadex and succinylcholine during electroconvulsive therapy. J Anesth. 2011 Dec;25(6):855-9. doi: 10.1007/s00540-011-1236-y. Epub 2011 Sep 24. — View Citation

Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0. — View Citation

Lisanby SH. Electroconvulsive therapy for depression. N Engl J Med. 2007 Nov 8;357(19):1939-45. doi: 10.1056/NEJMct075234. No abstract available. — View Citation

Mirzakhani H, Guchelaar HJ, Welch CA, Cusin C, Doran ME, MacDonald TO, Bittner EA, Eikermann M, Nozari A. Minimum Effective Doses of Succinylcholine and Rocuronium During Electroconvulsive Therapy: A Prospective, Randomized, Crossover Trial. Anesth Analg. 2016 Sep;123(3):587-96. doi: 10.1213/ANE.0000000000001218. — View Citation

Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4. — View Citation

Sparr HJ, Vermeyen KM, Beaufort AM, Rietbergen H, Proost JH, Saldien V, Velik-Salchner C, Wierda JM. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics. Anesthesiology. 2007 May;106(5):935-43. doi: 10.1097/01.anes.0000265152.78943.74. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery Time of T1 to 90% Baseline	The time of neuromuscular recovery from sugammadex 4mg/kg dose reversal rocuronium at 0.6 mg/kg compared with traditionally used succinylcholine in electroconvulsive therapy (ECT).	30 minutes
Secondary	Number of Participants With Treatment or Emergent Adverse Events of the Drugs	To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population	24 hours after the procedure