Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time

• ClinicalTrials.gov Identifier: NCT01567852
• Recruitment Status: Completed
• First Posted: March 30, 2012
• Results First Posted: December 30, 2014
• Last Update Posted: December 30, 2014
• Sponsor: University of New Mexico
• Information provided by (Responsible Party): University of New Mexico

Tracking Information

• First Submitted Date: March 28, 2012
• First Posted Date: March 30, 2012
• Results First Submitted Date: May 21, 2014
• Results First Posted Date: December 30, 2014
• Last Update Posted Date: December 30, 2014
• Study Start Date: August 2011
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 15, 2014)

• Re-orientation Time [ Time Frame: 1 hour ]
  Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.
• Recovery Time [ Time Frame: 1 hour ]
  Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.

Original Primary Outcome Measures (submitted: March 29, 2012)

• Re-orientation Time [ Time Frame: 1 hour ]
  Patients will be reoriented to baseline status more quickly with ketamine than with methohexital
• Recovery Time [ Time Frame: 1 hour ]
  Patients undergoing ECT treatments will recover in the post-anesthesia care unit more quickly after a ketamine induction compared to a methohexital induction

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time
• Official Title: The Use of Ketamine Versus Methohexital for Electroconvulsive Therapy: A Cross-Over Comparative Study on Patient Recovery and Re-Orientation Time
• Brief Summary: When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.
• Detailed Description: ECT treatments are done under general anesthesia, and the induction is commonly done with methohexital. We will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Post-anesthesia Recovery
• Orientation

Intervention

• Drug: Ketamine
  Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
• Drug: Methohexital
  Methohexital (1.5mg/kg) will be given for induction

Study Arms

• Experimental: Ketamine First
  This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine
  Interventions:

  • Drug: Ketamine
  • Drug: Methohexital
• Experimental: Methohexital First
  This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.
  Interventions:

  • Drug: Ketamine
  • Drug: Methohexital

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 15, 2014): 20
• Original Estimated Enrollment (submitted: March 29, 2012): 30
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All patients eligible for ECT with a primary mood disorder (bipolar disorder, major depressive disorder) will be eligible to participate in this study. - Patients must have decisional capacity and must be able to consent for this study.

Exclusion Criteria:

• patients with a primary psychotic disorder (schizophrenia, schizoaffective disorder); patients designated as having an American Society of Anesthesiologist (ASA) Status of greater than 3;
• patients with a known allergic reactions to methohexital , ketamine and succinylcholine;
• patients with current or previous history of aneurysms, intracranial bleeds, or intracranial hypertension;
• patients with uncontrolled severe hypertension.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01567852
• Other Study ID Numbers: HRRC#: 11-236
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of New Mexico
• Original Responsible Party: Same as current
• Current Study Sponsor: University of New Mexico
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tony Yen, MD; University of New Mexico

• PRS Account: University of New Mexico
• Verification Date: June 2014