Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy

NCT ID: NCT02267980

Last Updated: 2014-10-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group SK

Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Inhalation anesthetic agent

Ketamine

Intervention Type DRUG

Intravenous anesthetic agent

Group SS

Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner.

Group Type PLACEBO_COMPARATOR

Sevoflurane

Intervention Type DRUG

Inhalation anesthetic agent

Saline

Intervention Type DRUG

Isotonic solution for placebo group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sevoflurane

Inhalation anesthetic agent

Intervention Type DRUG

Ketamine

Intravenous anesthetic agent

Intervention Type DRUG

Saline

Isotonic solution for placebo group

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sevoflurane (sevorane) Ketamine (Ketalar) 50mg/mL injection Isotonic solution

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Major depressive patients

Exclusion Criteria

* Pregnancy
* Have a history of myocardial infarction in the previous six months
* Atrial fibrillation or flutter
* Heart block
* Unregulated hypertension
* Cerebrovascular diseases
* A known drug allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Feray Erdil

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Feray Erdil, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Feray Erdil, MD

Role: CONTACT

904223410660 ext. 3148

Mahmut Durmus, MD

Role: CONTACT

904223410660 ext. 3105

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mahmut Durmus, Prof Dr

Role: primary

904223410660 ext. 3105

References

Explore related publications, articles, or registry entries linked to this study.

Yalcin S, Aydogan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgic T. Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. J Anesth. 2012 Aug;26(4):562-7. doi: 10.1007/s00540-012-1378-6. Epub 2012 May 24.

Reference Type RESULT
PMID: 22623080 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Inonu 2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pro-Epileptic Effects of IV Ketamine
NCT06741930 COMPLETED PHASE4
Sevoflurane Induced Emergence Agitation
NCT02022488 COMPLETED PHASE4
Ketamine Versus Propofol as ICU Sedation
NCT06243822 COMPLETED PHASE4