Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT00750906
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2008-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ECT/Succinylcholine: Biochemical, Serum and Cardiovascular Changes
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
The Muscle Biochemical, Serum Potassium and Cardiovascular Changes After Succinylcholine in Patients Undergoing Electroconvulsive Therapy.
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study on hold since 2009. Awaiting FDA approval of Sugammdex to complete second arm of study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to determine the pharmacodynamics, cardiovascular and biochemical effects of succinylcholine when given during electroconvulsive therapy. (ECT). This is a single center, prospective, study in patients who will be receiving ECT as indicated and prescribed by their psychiatrist. The study will be performed twice on each patient, 48-72 hours apart during consecutively scheduled ECT procedures.
Detailed Description:
Patients will receive the anesthetic that is traditionally given which includes appropriate doses of succinylcholine. Serum potassium and creatinine phosphokinase (CK) levels will be determined pre and post anesthesia; serum and urine myoglobin will be determined post anesthesia. Vital signs data \[i.e., heart rate (arrhythmias) and arterial blood pressure\] will be compared pre and post anesthesia. In addition patients will be asked about the presence of muscle pain (myalgia) 1 hour before discharge from the recovery room and the following day post ECT.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: