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

Deep Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165848
• Other study ID #: 11260011
• Secondary ID: Ayça Tuba Dumanl
• Status: Completed
• Start date: July 9, 2020
• Est. completion date: June 7, 2021

Study information

• Verified date: December 2023
• Source: T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 7, 2021
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Deep Sedation
• Depression

Locations

Country	Name	City	State
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View 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):40 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hamilton Anxiety Rating Scale (HAM-A)	For anxiety; Hamilton Anxiety Rating Scale (HAM-A) was administered by the psychiatrist .	72 hours
Primary	Beck Suicidal Ideation Scale (BSSI)	To determine whether there is suicidal ideation; Beck Suicidal Ideation Scale (BSSI) was administered by the psychiatrist .	72 hours