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

NCT03532178 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MISP#56343
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuromuscular Blockade

Keywords

Electroconvulsive Therapy, Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Treatment or Emergent Adverse Events of the Drugs

  24 hours after the procedure

Study Arms (2)

Group A

EXPERIMENTAL

rocuronium + sugammadex / succinylcholine + normal saline

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

Group B

EXPERIMENTAL

succinylcholine + normal saline / rocuronium + sugammadex

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

Interventions

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

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.

Also known as: Rocuronium: Zemuron. Sugammadex: Bridion. Succinylcholine: Suxamethonium

Group A

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

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UCSF Parnassus Campus

San Francisco, California, 94143, United States

Location

Related Publications (11)

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

  PMID: 17989386 BACKGROUND

• 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.

  PMID: 24571807 BACKGROUND

• 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.

  PMID: 7618742 BACKGROUND

• 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.

  PMID: 7386911 BACKGROUND

• 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.

  PMID: 16192761 BACKGROUND

• 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.

  PMID: 4248487 BACKGROUND

• 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.

  PMID: 20442260 BACKGROUND

• 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.

  PMID: 19387176 BACKGROUND

• 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.

  PMID: 26967896 BACKGROUND

• 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.

  PMID: 17457124 BACKGROUND

• 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.

  PMID: 21947754 BACKGROUND

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Chanhung Lee
• Organization: UCaliforniaSF

chanhung.lee@ucsf.edu

4154762131

Study Officials

• Chanhung Lee, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization of treatment groups will be blinded to the patients themselves, the psychiatrists and outcome assessors, except the anesthesiologists who will administer the drugs.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be randomized to one of the two drug groups to start with, and will switch to the other group for the next treatment period. For the study, each participant will take two treatments in a random order: (1) rocuronium to be reversed by sugammadex, and (2) succinylcholine plus normal saline placebo.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: May 22, 2018
• Study Start: January 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: April 1, 2022
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)