Three Anaesthesic Method in Electroconvulsive Theraphy

NCT ID: NCT01759589

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-08-31

Brief Summary

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To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.

Detailed Description

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The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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propofol (Group P)

The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction

Group Type PLACEBO_COMPARATOR

Propofol

Intervention Type DRUG

1 mg/kg propofol IV (over 15 sec) during anesthesia induction

remifentanil and propofol (Group R)

Patients in Group R received remifentanil 1 µg/kg IV (over 60 sec) and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction

Group Type ACTIVE_COMPARATOR

Remifentanil and propofol

Intervention Type DRUG

1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction

sevoflurane (Group S)

In Group S, sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered, at which time it was stopped.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered

Interventions

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Propofol

1 mg/kg propofol IV (over 15 sec) during anesthesia induction

Intervention Type DRUG

Remifentanil and propofol

1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction

Intervention Type DRUG

Sevoflurane

Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered

Intervention Type DRUG

Other Intervention Names

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Intravenous anesthetic agent Opioid and intravenous anesthetic agent Volatil anesthetic

Eligibility Criteria

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Inclusion Criteria

* Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
* Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia)

Exclusion Criteria

* Involuntary patient status
* Patients with known or self-declared needle or mask phobia
* Pregnancy
* Asthma
* Cerebrovascular disease,
* History of myocardial infarction in the previous 6 months,
* Atrial fibrillation or flutter,heart block,
* A known or family history of reactions to the study drugs.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Zekine Begec

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zekine Begec

Role: STUDY_DIRECTOR

Locations

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Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Toprak HI, Gedik E, Begec Z, Ozturk E, Kaya B, Ersoy MO. Sevoflurane as an alternative anaesthetic for electroconvulsive therapy. J ECT. 2005 Jun;21(2):108-10. doi: 10.1097/01.yct.0000166633.73555.28.

Reference Type RESULT
PMID: 15905753 (View on PubMed)

Other Identifiers

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Inonu University

Identifier Type: OTHER

Identifier Source: secondary_id

Inonu University Anesthesia

Identifier Type: -

Identifier Source: org_study_id

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