NCT01759589

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

4 months

First QC Date

December 14, 2012

Last Update Submit

December 31, 2012

Conditions

Anesthesia

Keywords

electroconvulsive therapy,sevoflurane,propofol,remifentanil

Outcome Measures

Primary Outcomes (1)

  • Seizure duration

    After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.

    The patients were observed about seizure up to ten minutes after electrical stimulation

Secondary Outcomes (3)

  • postictal suppression index

    completing seizure in one hour

  • Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands)

    after seizure in one hour in operation room.

  • Hemodynamic variables

    Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.

Study Arms (3)

propofol (Group P)

PLACEBO COMPARATOR

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

Drug: Propofol

remifentanil and propofol (Group R)

ACTIVE COMPARATOR

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

Drug: Remifentanil and propofol

sevoflurane (Group S)

ACTIVE COMPARATOR

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.

Drug: Sevoflurane

Interventions

PropofolDRUG

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

Also known as: Intravenous anesthetic agent
propofol (Group P)
Remifentanil and propofolDRUG

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

Also known as: Opioid and intravenous anesthetic agent
remifentanil and propofol (Group R)
SevofluraneDRUG

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

Also known as: Volatil anesthetic
sevoflurane (Group S)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 15905753RESULT

MeSH Terms

Interventions

PropofolRemifentanilAnalgesics, OpioidSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Zekine Begec

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2012

First Posted

January 3, 2013

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations

TU(1)