Randomised, triple-blind, parallel-group trial (n=204) testing a single 0.2 mg/kg IV esketamine injection versus 5 ml 0.9% saline in females undergoing surgical abortion with sleep disturbance.
This parallel-group, randomised, triple-blind study evaluates whether a single low dose of esketamine given during surgical abortion improves sleep disturbance in women (gestation <12 weeks).
Participants receive a single intravenous injection of esketamine 0.2 mg/kg or 5 ml 0.9% normal saline after the beginning of surgery; outcomes include measures of sleep disturbance, postoperative recovery, delirium and pain.
Safety and tolerability will be monitored intraoperatively and postoperatively; primary purpose is treatment of sleep disturbance associated with surgical abortion.
Single IV 0.2 mg/kg esketamine administered after start of surgery.
Single injection after beginning of surgery
Single IV 5 ml 0.9% normal saline administered after start of surgery.
5 ml 0.9% normal saline