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

NCT02271555 | Unknown Phase 4

• 1 other identifier: Inonu 3
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Haemodynamic Rebound

Keywords

electroconvulsive therapy; sevoflurane; remifentanil

Outcome Measures

Primary Outcomes (1)

• The effects of remifentanil on the heart rate after electroconvulsive therapy

  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).

  20 minute

Secondary Outcomes (2)

• Seizure duration

  20 minute

• The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy

  20 minute

Study Arms (2)

sevoflurane-remifentanil (Group SR)

ACTIVE COMPARATOR

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; Drug: Remifentanil

sevoflurane-saline (Group SS)

PLACEBO COMPARATOR

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; Drug: Saline

Interventions

Sevoflurane DRUG

Anesthetic induction will be achieved via 8% sevoflurane

Also known as: Sevorane

sevoflurane-remifentanil (Group SR); sevoflurane-saline (Group SS)

Remifentanil DRUG

After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.

Also known as: Ultiva

sevoflurane-remifentanil (Group SR)

Saline DRUG

After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.

Also known as: 0.9% isotonic solution

sevoflurane-saline (Group SS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Major depressive patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 21116659 RESULT

MeSH Terms

Interventions

Sevoflurane; Remifentanil; Sodium Chloride; Isotonic Solutions

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Solutions; Pharmaceutical Preparations

Study Officials

• Feray Erdil, MD

  İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feray Erdil, MD

CONTACT

+90 422 341 06 60; feray.erdil@inonu.edu.tr

Mahmut Durmus, MD

CONTACT

+90 422 341 06 60; mahmut.durmus@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

TU (1)