What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are DEX 0.2 μg/kg/h., SGB, or 0.9% Sodium Chloride (Placebo). The registry lists allocation as randomized. Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs.
They plan to enroll about 100 people at Huai'an. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
Effects of Stellate Ganglion Block Combined With Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled 2×2 Factorial Trial
Interventions: DEX 0.2 μg/kg/h., SGB, 0.9% Sodium Chloride (Placebo), Sham Stellate Ganglion Block
Primary outcome (registry wording): St. Mary's Hospital Sleep Questionnaire Score 1 Day Before Surgery