Clinical trial NCT06165848: Effects Of Different Anesthesia Applications On Mood, Depression, And Anxiety Levels In Burn Patients
Official title: Effects Of Different Anesthesia Applications On Mood, Depression, And Anxiety Levels In Burn Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Unspecified Degree
Deep Sedation
Keywords: Burn patient
Depression
Ketamine
Suicidal tendencies
Lead sponsor: T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sexes aged 18 to 65 years will be included in the study.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS),
timeFrame: 72 hours
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 72 hours
measure: Beck Suicidal Ideation Scale (BSSI)
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
Study officials:
affiliation: Ankara Bilkent Şehir Hastanesi
name: Ayça Tuba Özcan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.