Effects Of Different Anesthesia Applications On Mood, Depression, And Anxiety Levels In Burn Patients

December 11, 2023 updated by: T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi
Adequate and effective pain management and prevention of depression are essential in burn patients. This study aims to investigate the effects of ketamine sedation in burn patients in terms of mood disorders, depression, anxiety, and suicidal tendency during intensive care follow-up in the postoperative period.

Study Overview

Status

Completed

Conditions

Detailed Description

Aim: Adequate and effective pain management and prevention of depression are essential in burn patients. This study aims to investigate the effects of ketamine sedation in burn patients in terms of mood disorders, depression, anxiety, and suicidal tendency during intensive care follow-up in the postoperative period.

Methods: The study was conducted with 67 patients between 18 and 65 years of age, who were ASA I-II class, had basic communication skills, no previous diagnosis of psychiatric illness, and no history of neuropsychiatric or cognitive disease or related treatment. After preoxygenation, anesthesia induction was performed with 2 mg/kg IV propofol and 1 mcg/kg IV fentanyl in the general anesthesia group. Anesthesia was continued with a mixture of 0.3-0.5 mcg/kg/min remifentanil, 2% sevoflurane, 50% air, 50% oxygen. In the sedation group, 1 mcg/kg IV fentanyl and 1 mg/kg IV ketamine were administered at induction; anesthesia was maintained by adding 30-50 mg IV propofol if necessary. The Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A), and the Beck Scale for Suicide Ideation (BSSI) were administered preoperatively and on postoperative day one by the psychiatrist.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent Sehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients of both sexes aged 18 to 65 years will be included in the study.

Description

Inclusion Criteria:

  • Who were ASA I-II class,
  • Had basic communication skills,
  • No previous diagnosis of psychiatric illness,
  • No history of neuropsychiatric or cognitive disease or related treatment.

Exclusion Criteria:

  • With a previous diagnosis of psychiatric illness,
  • Neuropsychiatric or cognitive illness,
  • Or a history of related treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
General anesthesia
After preoxygenation, anesthesia induction was performed with 2 mg/kg IV propofol and 1 mcg/kg IV fentanyl in the general anesthesia group. Anesthesia was maintained with a mixture of 0.3-0.5 mcg/kg/min remifentanil, 2% sevoflurane, 50% air, 50% oxygen. The Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A), and the Beck Scale for Suicide Ideation (BSSI) were administered preoperatively and on postoperative day one by a psychiatrist.
Sedation anesthesia
In the sedation group, 1 mcg/kg IV fentanyl and 1 mg/kg IV ketamine were administered at induction, and 30-50 mg IV propofol was added if necessary to maintain anesthesia. The Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A), and the Beck Scale for Suicide Ideation (BSSI) were administered preoperatively and on postoperative day one by a psychiatrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS),
Time Frame: 72 hours
In order to determine whether there is negative mood and depression; Montgomery-Asberg Depression Rating Scale (MADRS) was administered by the psychiatrist .
72 hours
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: 72 hours
For anxiety; Hamilton Anxiety Rating Scale (HAM-A) was administered by the psychiatrist .
72 hours
Beck Suicidal Ideation Scale (BSSI)
Time Frame: 72 hours
To determine whether there is suicidal ideation; Beck Suicidal Ideation Scale (BSSI) was administered by the psychiatrist .
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi

Investigators

  • Principal Investigator: Ayça Tuba Özcan, Ankara Bilkent Sehir Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Actual)

August 10, 2020

Study Completion (Actual)

June 7, 2021

Study Registration Dates

First Submitted

August 20, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11260011
  • Ayça Tuba Dumanlı Özcan (Other Identifier: Ankara Şehir Hastanesi, Anesteziyoloji ve Reanimasyon)
  • Betül Akaycan (Other Identifier: Ankara Şehir Hastanesi, Psikiyatri)
  • Serdar Süleyman Can (Other Identifier: Ankara Şehir Hastanesi, Psikiyatri)
  • Özlem Karakaya (Other Identifier: Ankara Şehir Hastanesi, Psikiyatri)
  • Emine Sönmez (Other Identifier: Ankara Şehir Hastanesi, Anesteziyoloji ve Reanimasyon)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared with other researchers.

IPD Sharing Time Frame

10 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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