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

NCT ID: NCT06165848

Last Updated: 2023-12-12

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

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-09

Study Completion Date

2021-06-07

Brief Summary

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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

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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.

Conditions

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Burn Unspecified Degree Deep Sedation

Keywords

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Burn patient Depression Ketamine Suicidal tendencies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayça Tuba Özcan

Role: PRINCIPAL_INVESTIGATOR

Ankara Bilkent Şehir Hastanesi

Locations

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Ankara Bilkent Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 30922101 (View on PubMed)

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.

Reference Type RESULT
PMID: 23982301 (View on PubMed)

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.

Reference Type RESULT
PMID: 31759333 (View on PubMed)

Other Identifiers

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Ayça Tuba Dumanlı Özcan

Identifier Type: OTHER

Identifier Source: secondary_id

Betül Akaycan

Identifier Type: OTHER

Identifier Source: secondary_id

Serdar Süleyman Can

Identifier Type: OTHER

Identifier Source: secondary_id

Özlem Karakaya

Identifier Type: OTHER

Identifier Source: secondary_id

Emine Sönmez

Identifier Type: OTHER

Identifier Source: secondary_id

11260011

Identifier Type: -

Identifier Source: org_study_id