Sevoflurane in Electroconvulsive Therapy | NCT01905904

Studies
Sevoflurane in Electroconvulsive Therapy

NCT01905904

Sponsor

Inonu University

Status

Completed

Last Update Posted

May 16, 2019Actual

Enrollment

25Actual

Phase

Phase 4

Conditions

ECT
Anesthesia

Interventions

sevorane

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013Actual

Primary Completion Date

May 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jul 16, 2013

First Submission Date that Met QC Criteria

Jul 22, 2013

First Posted Date

Jul 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2019

Last Update Posted Date

May 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study was to investigate the effects of different doses of sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles

Detailed Description

Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times were recorded.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sevorane	Active Comparator	Sevorane 4% concentration during anesthesia induction	Drug: sevorane
sevorane %7	Active Comparator	Sevorane 7% concentration during anesthesia induction	Drug: sevorane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sevorane	Drug	Sevorane 4% Sevorane 7%	sevorane sevorane %7

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure		taken prior to the seizure

Secondary Outcomes

Measure	Description	Time Frame
sevoflurane used in electroconvulsive therapy (ECT) on hemodynamic response.		taken prior to the seizure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Study included 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia

Exclusion Criteria:

Pregnancy
Cerebrovascular disease
Epilepsy
Unstable cardiovascular disease
Chronic obstructive pulmonary disease; and
Renal or hepatic failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Huseyin Toprak, Professor	Inonu University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inonu Unıversity School of Medicine		Malatya		44100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D012640	Seizures

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided