NCT01905904

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

July 16, 2013

Last Update Submit

May 15, 2019

Conditions

ECTAnesthesia

Keywords

electroconvulsive therapyseizuressevoflurane

Outcome Measures

Primary Outcomes (1)

  • sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure

    taken prior to the seizure

Secondary Outcomes (1)

  • sevoflurane used in electroconvulsive therapy (ECT) on hemodynamic response.

    taken prior to the seizure

Study Arms (2)

sevorane

ACTIVE COMPARATOR

Sevorane 4% concentration during anesthesia induction

Drug: sevorane

sevorane %7

ACTIVE COMPARATOR

Sevorane 7% concentration during anesthesia induction

Drug: sevorane

Interventions

sevoraneDRUG

Sevorane 4% Sevorane 7%

Also known as: Sevoflurane
sevoranesevorane %7

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu Unıversity School of Medicine

Malatya, 44100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Seizures

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Huseyin Toprak, Professor

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant profesor

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 23, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

May 16, 2019

Record last verified: 2019-05

Locations

TU(1)