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Neuromuscular BlockadePhase 2CRoSSECTNCT03532178

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

A Phase 2 study testing Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline and Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex; in people with Neuromuscular Blockade, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators propose to compare the recovery of neuromuscular blockade from rocuronium reversal by sugammadex to succinylcholine in ECT. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuromuscular Blockade
What is being tested?
Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline and Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
1 Jan 2019to 1 Apr 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Parnassus Campus

    San Francisco, California, 94143

Other trials in United States

About this study

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

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

Read the detailed 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.

Being tested
Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline, Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;
Keywords
Electroconvulsive Therapy, Neuromuscular Blockade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +salineDrug

    Also called Rocuronium: Zemuron. Sugammadex: Bridion. Succinylcholine: Suxamethonium

    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;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.

Study groups in NCT03532178
Study groupRoleWhat they receive
Group AExperimentalrocuronium + sugammadex / succinylcholine + normal saline
Receives: Drug: Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline
Group BExperimentalsuccinylcholine + normal saline / rocuronium + sugammadex
Receives: Drug: Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 30 minutes

Secondary outcomes (1)

  1. 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

    Measured: 24 hours after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start1 Jan 2019
  3. Primary completion31 Mar 2022
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532178
Sponsor's protocol ID
MISP#56343
Acronym
CRoSSECT
Status last verified
Aug 2023
First submitted
3 Apr 2018
Last updated
8 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 17989386

  • 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.

    PubMed 24571807

  • 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.

    PubMed 7618742

  • 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.

    PubMed 7386911

  • 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.

    PubMed 16192761

  • 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.

    PubMed 4248487

  • 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.

    PubMed 20442260

  • 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.

    PubMed 19387176

  • 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.

    PubMed 26967896

  • 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.

    PubMed 17457124

  • 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.

    PubMed 21947754

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline and Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex; in people with Neuromuscular Blockade, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery Time of T1 to 90% Baseline (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532178, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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