Effects of Intraoperative Sodium Oxybate Infusion on Post-Operative Sleep Quality in Patients Undergoing Gynecological Laparoscopic Surgery: A Randomized Clinical Trial.

Study objective: Post-operative sleep quality is an important factor that influences post-operative recovery. Sodium oxybate has been used to treat sleep disturbances associated with various pathological conditions. However, whether intraoperative intravenous infusion of sodium oxybate improves post-operative sleep quality is unknown. This study aimed to examine the effects of sodium oxybate on the post-operative sleep quality of patients who underwent gynecological laparoscopic surgery. Design: A single-center, prospective, two-arm, double-blinded randomized controlled trial. Setting: The Shengjing Hospital of China Medical University in Liaoning, China. Patients: We enrolled 180 adult patients (90 for each group) undergoing elective gynecological laparoscopic surgery, and 178 patients (89 for each group) were included in the final analysis. Interventions: Patients were randomly allocated in a 1:1 ratio to receive either sodium oxybate (30 mg kg-1) or an equivalent volume of saline after intubation. The patients, anesthetists, and follow-up staff were blinded to group assignment. Measurements: The primary outcome was sleep quality measured using the Richards-Campbell Sleep Questionnaire (RCSQ) on post-operative days (PODs) one and three. Secondary outcomes included post-operative pain measured using the visual analog scale, sleep quality at one and three months post-operatively measured using the Pittsburgh Sleep Quality Index, and factors associated with post-operative sleep quality. Main results: Analysis with generalized estimating equations showed that sodium oxybate significantly improved post-operative sleep quality, as represented by increased total RCSQ scores (mean difference (95% CI); 9 (2, 16), P = 0.010) over PODs one and three. There was no difference in post-operative pain between the two groups over PODs one and three or in post-operative sleep quality over one and three months post-operatively. Age, surgery type, start time of surgery, and use of sufentanil-based patient-controlled intravenous analgesia were significantly associated with post-operative sleep quality. Conclusions: Intraoperative sodium oxybate infusion improved post-operative sleep in patients who underwent gynecological laparoscopic surgery. Trial registration. Chinese Clinical Trial Registry, Clinical trial number: ChiCTR2200061460.