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CompletedNCT06165848Updated Dec 12, 2023

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

An observational study in Burn Unspecified Degree and Deep Sedation, sponsored by T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
67
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Burn Unspecified Degree
  • Deep Sedation

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Keywords

  • Burn patient
  • Depression
  • Ketamine
  • Suicidal tendencies
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In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 67 is above the median of 55 across 135 observational studies indexed under Burns.

Browse Burns studies →

Lead sponsor

This is the only study on the registry with T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
67 participants (actual)
Target follow-up
3 Days
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 72 hours

  2. Hamilton Anxiety Rating Scale (HAM-A)

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

    Time frame: 72 hours

  3. Beck Suicidal Ideation Scale (BSSI)

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

    Time frame: 72 hours

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Study locations

1 site
  • Ankara Bilkent Şehir Hastanesi
    Ankara, 06800, Turkey
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References and documents

Publications

  • 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. PubMed 30922101 ↗
  • 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. PubMed 23982301 ↗
  • 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. PubMed 31759333 ↗

Individual participant data

Plan to share: Yes — IPD will be shared with other researchers.

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06165848
Lead sponsor
T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
Jul 9, 2020
Primary completion
Aug 10, 2020
Completion
Jun 7, 2021
Last update
Dec 12, 2023

Study contacts

Ayça Tuba Özcan
principal investigator · Ankara Bilkent Şehir Hastanesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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