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

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ClinicalTrials.gov Identifier: NCT02271555
Recruitment Status : Unknown
Verified October 2014 by Feray Erdil, Inonu University.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Feray Erdil, Inonu University

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

Condition or disease Intervention/treatment Phase
Haemodynamic Rebound Drug: Sevoflurane Drug: Remifentanil Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya
Study Start Date : October 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
Drug: Sevoflurane
Anesthetic induction will be achieved via 8% sevoflurane
Other Name: Sevorane

Drug: Saline
After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.
Other Name: 0.9% isotonic solution




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Seizure duration [ Time Frame: 20 minute ]
    During electroconvulsive therapy

  2. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02271555


Contacts
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Contact: Feray Erdil, MD +90 422 341 06 60 ext 3148 feray.erdil@inonu.edu.tr
Contact: Mahmut Durmus, MD +90 422 341 06 60 ext 3105 mahmut.durmus@inonu.edu.tr

Locations
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Turkey
Turgut Ozal Medical Center
Malatya, Turkey, 44315
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Feray Erdil, MD İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation
Publications of Results:
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Responsible Party: Feray Erdil, Associated professor, Inonu University
ClinicalTrials.gov Identifier: NCT02271555    
Other Study ID Numbers: Inonu 3
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by Feray Erdil, Inonu University:
electroconvulsive therapy
sevoflurane
remifentanil
Additional relevant MeSH terms:
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Remifentanil
Sevoflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics