Clinical trial NCT03086148: Ketamine and Postoperative Depressive Symptom-PASSION
Official title: Effect of Low-dose Ketamine on Postoperative Depressive Symptom in Patients Undergoing Intracranial Tumor Resection (PASSION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perioperative depression symptom (PDS) is one of the common mental comorbidity, and influences the clinical outcomes and prognosis. However, there is no rapid acting treatment to deal with it during the limited hospital stay. This study aims to determine whether ketamine could improve the depressive symptom of peirioperative patients. It will also examine the safety for administrating ketamine as an antidepressant intraoperatively. Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium. This trial also will bring great concerns on patients with perioperative mental health and explore the measures to improve their psycho-related prognosis.


Eligibility criteria: Inclusion Criteria:

1. Brain tumor located supratentorial area and need to receive elective craniotomy;
2. Moderate to severe depressive symptom measured by the qualified psychiatric doctors.
3. Ages between 18 and 65 years old.
4. American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

1. History of epilepsy;
2. Major depression disorder patients undergoing antidepressive therapy within 2 weeks; 3 Psychiatric illness; 4 Drug abuse; 5 History of allergy to the research drug; 6 Tumor located in the Wernick area, Broca area or the frontal pole; 7 Hyperthyroidism; 8 Patients can not cooperate with investigators on psychiatric assessments; 9 Pregnant or breast-feeding woman; 10 refuse to sign inform consent.

Primary outcomes:
measure: Response rate
timeFrame: Postoperative 3 days
Secondary outcomes:
measure: The remission rate
timeFrame: Postoperative 3 days and discharge.
measure: Anxiety symptom
timeFrame: Postoperative 3 days.
measure: Postoperative delirium
timeFrame: Postoperative 1 day.
measure: Severe pain
timeFrame: Postoperative 3 days.
measure: Postoperative 30-day quality of life reported by KPS
timeFrame: Postoperative 30 days
measure: Psychiatric outcomes and complications
timeFrame: Postoperative 3 days and discharge.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TianTan Hospital
Study officials:
affiliation: Department of Anesthesiology, Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph.D
role: STUDY_CHAIR
References:
citation: Zhou Y, Sun W, Zhang G, Wang A, Lin S, Chan MTV, Peng Y, Wang G, Han R. Ketamine Alleviates Depressive Symptoms in Patients Undergoing Intracranial Tumor Resection: A Randomized Controlled Trial. Anesth Analg. 2021 Dec 1;133(6):1588-1597. doi: 10.1213/ANE.0000000000005752.
citation: Zhou Y, Peng Y, Fang J, Sun W, Zhang G, Zhen L, Wang G, Han R. Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial. Trials. 2018 Aug 29;19(1):463. doi: 10.1186/s13063-018-2831-0.