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.
Postoperative depression is a common complication that can impair recovery and quality of life; idiopathic intracranial hypertension (IIH) patients undergoing lumbo-peritoneal shunting have high rates of anxiety and depression.
A single intraoperative dose of ketamine has rapid antidepressant effects in prior human and animal studies via NMDA antagonism, increases in BDNF, and disinhibition of reward circuits, providing rationale for perioperative use to reduce postoperative depressive symptoms.
This randomised, triple-blind, parallel Phase IV trial will compare intraoperative ketamine (50 ml at 1 mg/ml; total 50 mg) versus 50 ml normal saline in 60 patients undergoing lumbo-peritoneal shunt insertion, assessing depressive symptoms postoperatively.
50-ml normal saline (placebo comparator).
50 ml normal saline intraoperative placebo.
Ketamine 1 mg/ml, 50 ml (total 50 mg) intraoperative infusion.
50 ml at 1 mg/ml (total 50 mg); intraoperative infusion; other name 'katalar'.