This Phase IV interventional trial (n=60) aims to investigate the effectiveness of intraoperative ketamine in reducing postoperative depressive symptoms in patients undergoing lumbo-peritoneal shunt insertion.
Conducted by Benha University in Egypt, the study focuses on patients aged 20 to 44 years with moderate to severe depressive symptoms and an expected hospital stay of at least 7 days. Participants will be randomly assigned to receive either ketamine or normal saline as a placebo during the procedure.
The primary outcome measure is the rate of response to treating postoperative depression, defined as a relative reduction of more than 50% from the baseline 10-item MADRS score at 3 postoperative days. Secondary outcome measures include the remission rate, incidence of severe pain, and quality of life within the first 48 hours postoperatively.
The study aims to assess whether intraoperative ketamine administration can effectively alleviate postoperative depressive symptoms in patients undergoing lumbar-peritoneal shunt insertion, potentially improving patient outcomes and quality of life.
Trial Details
Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations . High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .NCT Number NCT06060210