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ECT/Succinylcholine: Biochemical, Serum and Cardiovascular Changes

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ClinicalTrials.gov Identifier: NCT00750906
Recruitment Status : Suspended (Study on hold since 2009. Awaiting FDA approval of Sugammdex to complete second arm of study.)
First Posted : September 11, 2008
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease
Depression

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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Muscle Biochemical, Serum Potassium and Cardiovascular Changes After Succinylcholine in Patients Undergoing Electroconvulsive Therapy.
Study Start Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing electroconvulsive therapy.
Criteria

Inclusion Criteria:

  1. A male or non-pregnant female aged 18 years and older
  2. American Society of Anesthesiologists physical status 1, 2, 3
  3. Scheduled to undergo electroconvulsive therapy under general anesthesia
  4. Have given written informed consent

Exclusion Criteria:

  1. Pregnant or nursing
  2. Any patient in the study investigators opinion who may not be suitable for research.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750906


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Director: Ronald D Miller, MD University of California, San Francisco
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00750906     History of Changes
Other Study ID Numbers: H898-32701
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Succinylcholine
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs