ECT/Succinylcholine: Biochemical, Serum and Cardiovascular Changes

This study has suspended participant recruitment.

(Study on hold since 2009. Awaiting FDA approval of Sugammdex to complete second arm of study.)

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00750906

First received: September 9, 2008

Last updated: March 6, 2013

Last verified: March 2013

History of Changes

Purpose

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
Depression


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	The Muscle Biochemical, Serum Potassium and Cardiovascular Changes After Succinylcholine in Patients Undergoing Electroconvulsive Therapy.

Resource links provided by NLM:

MedlinePlus related topics: Potassium

Drug Information available for: Succinylcholine chloride

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:


Estimated Enrollment:	20
Study Start Date:	October 2008

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients undergoing electroconvulsive therapy.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant or nursing
Any patient in the study investigators opinion who may not be suitable for research.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00750906 History of Changes
Other Study ID Numbers:	H898-32701
Study First Received:	September 9, 2008
Last Updated:	March 6, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Succinylcholine Neuromuscular Depolarizing Agents Neuromuscular Blocking Agents	Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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