Burn Unspecified DegreeNCT06165848
Effects Of Different Anesthesia Applications On Mood, Depression, And Anxiety Levels In Burn Patients
An observational study of Burn Unspecified Degree and Deep Sedation, run by T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Unspecified Degree, Deep Sedation
- Type of treatment
- Injection or infusion
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2020to 7 Jun 2021
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of both sexes aged 18 to 65 years will be included in the study.
Who may be able to join
- 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.
Who cannot join
- With a previous diagnosis of psychiatric illness,
- Neuropsychiatric or cognitive illness,
- Or a history of related treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Burn Unspecified Degree, Deep Sedation
- Keywords
- Burn patient, Depression, Ketamine, Suicidal tendencies
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 72 hours
Hamilton Anxiety Rating Scale (HAM-A)
For anxiety; Hamilton Anxiety Rating Scale (HAM-A) was administered by the psychiatrist .
Measured: 72 hours
Beck Suicidal Ideation Scale (BSSI)
To determine whether there is suicidal ideation; Beck Suicidal Ideation Scale (BSSI) was administered by the psychiatrist .
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start9 Jul 2020
- Primary completion10 Aug 2020
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burn Unspecified DegreeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayça Tuba Özcan, Principal investigator, Ankara Bilkent Şehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165848
- Sponsor's protocol ID
- 11260011
- Other IDs
- Ayça Tuba Dumanlı Özcan, Betül Akaycan, Serdar Süleyman Can, Özlem Karakaya, Emine Sönmez
- Status last verified
- Dec 2023
- First submitted
- 20 Aug 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other researchers.
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 30922101Murrough 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 23982301Phillips 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Different Anesthesia Applications On Mood, Depression, And Anxiety Levels In Burn Patients
- ClinicalTrials.gov ID
- NCT06165848
- Acronym / sponsor ID
- 11260011
- Conditions
- Burn Unspecified Degree, Deep Sedation
- Keywords
- Burn patient, Depression, Ketamine, Suicidal tendencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- T.C. Sağlık Bakanlığı Ankara Bilkent Şehir HastanesiUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes aged 18 to 65 years will be included in the study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- With a previous diagnosis of psychiatric illness,
- Neuropsychiatric or cognitive illness,
- Or a history of related treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS),
Time frame: 72 hours
In order to determine whether there is negative mood and depression; Montgomery-Asberg Depression Rating Scale (MADRS) was administered by the psychiatrist .
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 72 hours
For anxiety; Hamilton Anxiety Rating Scale (HAM-A) was administered by the psychiatrist .
Beck Suicidal Ideation Scale (BSSI)
Time frame: 72 hours
To determine whether there is suicidal ideation; Beck Suicidal Ideation Scale (BSSI) was administered by the psychiatrist .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Results publication: PubMed 30922101Phillips 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.
- Results publication: PubMed 23982301Murrough 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.
- Results publication: PubMed 31759333Phillips 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.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça Tuba Özcan principal investigator
Ankara Bilkent Şehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Unspecified Degree and Deep Sedation, run by T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS), (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06165848, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.