NCT02819375

Brief Summary

Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and other psychiatric diseases. Currently, most ECT procedures are carried out with muscle paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to establish an accurate balance between adequate anaesthesia depth and optimal seizure duration. We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol with remifentanil and propofol with ketamine), with respect to seizure duration and seizure quality in patients undergoing electroconvulsive therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

June 28, 2016

Last Update Submit

February 26, 2019

Conditions

AnesthesiaElectroconvulsive Therapy

Keywords

propofolketamineremifentanil

Outcome Measures

Primary Outcomes (1)

  • seizure activity

    Motor (EMG) and electroencephalogram (EEG) seizure durations

    intraoperative

Secondary Outcomes (3)

  • heart rate (HR)

    (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes

  • mean arterial pressure (MAP)

    (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes

  • recovery times

    intraoperative

Study Arms (3)

Group Propofol

ACTIVE COMPARATOR

anesthesia will induced 1 mg/kg propofol

Drug: Propofol

Group propofol/remifentanil

ACTIVE COMPARATOR

anesthesia will induced 0.5 mg/kg propofol and 1 µg/kg remifentanil

Drug: Propofol+Remifentanil

Group propofol/ketamine

ACTIVE COMPARATOR

anesthesia will induced propofol 0.5 mg/kg and ketamine 0.5 mg/kg

Drug: Propofol+Ketamine

Interventions

PropofolDRUG

1 mg/kg propofol

Also known as: Diprivan
Group Propofol
Propofol+RemifentanilDRUG

0.5 mg/kg propofol+0.5 mg/kg remifentanil

Also known as: Propofol+Ultiva
Group propofol/remifentanil
Propofol+KetamineDRUG

0.5 mg/kg propofol and 0.5 mg/kg ketamine

Also known as: Propofol+Ketalar
Group propofol/ketamine

Eligibility Criteria

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

You may qualify if:

  • Study include 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who scheduled for ECT sessions under general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Erdogan Kayhan G, Yucel A, Colak YZ, Ozgul U, Yologlu S, Karlidag R, Ersoy MO. Ketofol (mixture of ketamine and propofol) administration in electroconvulsive therapy. Anaesth Intensive Care. 2012 Mar;40(2):305-10. doi: 10.1177/0310057X1204000214.

    PMID: 22417026RESULT

  • Begec Z, Erdogan Kayhan G, Toprak HI, Sahin T, Konur H, Colak C, Durmus M, Ersoy MO. Sevoflurane alone and propofol with or without remifentanil for electroconvulsive therapy-a randomised, crossover study. Anaesth Intensive Care. 2013 Mar;41(2):202-6. doi: 10.1177/0310057X1304100209.

    PMID: 23530786RESULT

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ulku Ozgul, Ass.Prof.

    Inonu University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 30, 2016

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share