- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03532178
Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT) (CRoSSECT)
August 28, 2023 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- UCSF Parnassus Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
rocuronium + sugammadex / succinylcholine + normal 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.
Other Names:
|
Experimental: Group B
succinylcholine + normal saline / 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery Time of T1 to 90% Baseline
Time Frame: 30 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment or Emergent Adverse Events of the Drugs
Time Frame: 24 hours after the procedure
|
To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population
|
24 hours after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chanhung Lee, MD, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Lisanby SH. Electroconvulsive therapy for depression. N Engl J Med. 2007 Nov 8;357(19):1939-45. doi: 10.1056/NEJMct075234. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
May 9, 2018
First Posted (Actual)
May 22, 2018
Study Record Updates
Last Update Posted (Actual)
September 8, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MISP#56343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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