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

NCT06165848 | Completed

• 6 other identifiers: 11260011Ayça Tuba Dumanlı ÖzcanBetül AkaycanSerdar Süleyman CanÖzlem KarakayaEmine Sönmez
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burn Unspecified Degree; Deep Sedation

Keywords

Burn patient; Depression; Ketamine; Suicidal tendencies

Outcome Measures

Primary Outcomes (3)

• Montgomery-Asberg Depression Rating Scale (MADRS),

  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)

  For anxiety; Hamilton Anxiety Rating Scale (HAM-A) was administered by the psychiatrist .

  72 hours

• Beck Suicidal Ideation Scale (BSSI)

  To determine whether there is suicidal ideation; Beck Suicidal Ideation Scale (BSSI) was administered by the psychiatrist .

  72 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi: lead

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• Phillips JL, Norris S, Talbot J, Birmingham M, Hatchard T, Ortiz A, Owoeye O, Batten LA, Blier P. Single, Repeated, and Maintenance Ketamine Infusions for Treatment-Resistant Depression: A Randomized Controlled Trial. Am J Psychiatry. 2019 May 1;176(5):401-409. doi: 10.1176/appi.ajp.2018.18070834. Epub 2019 Mar 29.

  PMID: 30922101 RESULT

• Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.

  PMID: 23982301 RESULT

• Phillips JL, Norris S, Talbot J, Hatchard T, Ortiz A, Birmingham M, Owoeye O, Batten LA, Blier P. Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression. Neuropsychopharmacology. 2020 Mar;45(4):606-612. doi: 10.1038/s41386-019-0570-x. Epub 2019 Nov 23.

  PMID: 31759333 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ayça Tuba Özcan

  Ankara Bilkent Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: December 12, 2023
• Study Start: July 9, 2020
• Primary Completion: August 10, 2020
• Study Completion: June 7, 2021
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 10 years

Locations

TU (1)