The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy

• ClinicalTrials.gov Identifier: NCT02271555
• Recruitment Status: Unknown
• First Posted: October 22, 2014
• Last Update Posted: October 22, 2014
• Sponsor: Inonu University
• Information provided by (Responsible Party): Feray Erdil, Inonu University

Tracking Information

• First Submitted Date: October 16, 2014
• First Posted Date: October 22, 2014
• Last Update Posted Date: October 22, 2014
• Study Start Date: October 2014
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2014)

The effects of remifentanil on the heart rate after electroconvulsive therapy [ Time Frame: 20 minute ]

Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 20, 2014)

• Seizure duration [ Time Frame: 20 minute ]
  During electroconvulsive therapy
• The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy [ Time Frame: 20 minute ]
  Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).

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

Descriptive Information

• Brief Title: The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy
• Official Title: Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya
• Brief Summary: The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression
• Detailed Description: Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Haemodynamic Rebound

Intervention

• Drug: Sevoflurane
  Anesthetic induction will be achieved via 8% sevoflurane
  Other Name: Sevorane
• Drug: Remifentanil
  After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.
  Other Name: Ultiva
• Drug: Saline
  After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.
  Other Name: 0.9% isotonic solution

Study Arms

• Active Comparator: sevoflurane-remifentanil (Group SR)
  Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.
  Interventions:

  • Drug: Sevoflurane
  • Drug: Remifentanil
• Placebo Comparator: sevoflurane-saline (Group SS)
  Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. Placebo is 0.9% saline. After the loss of consciousness saline will be administered to Group sevoflurane-saline in the form of intravenous bolus.
  Interventions:

  • Drug: Sevoflurane
  • Drug: Saline

• Publications *: Nishikawa K, Higuchi M, Kawagishi T, Shimodate Y, Yamakage M. Effect of divided supplementation of remifentanil on seizure duration and hemodynamic responses during electroconvulsive therapy under propofol anesthesia. J Anesth. 2011 Feb;25(1):29-33. doi: 10.1007/s00540-010-1049-4. Epub 2010 Nov 30.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 20, 2014): 58
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Major depressive patients

Exclusion Criteria:

• younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT02271555
• Other Study ID Numbers: Inonu 3
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Feray Erdil, Inonu University
• Study Sponsor: Inonu University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Feray Erdil, MD; İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation

• PRS Account: Inonu University
• Verification Date: October 2014