Effects of intraoperative sodium oxybate infusion on post-operative sleep quality in patients undergoing gynecological laparoscopic surgery: A randomized clinical trial

Abstract

Study objectivePost-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. DesignA single-center, prospective, two-arm, double-blinded randomized controlled trial. SettingThe Shengjing Hospital of China Medical University in Liaoning, China. PatientsWe 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. InterventionsPatients 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. MeasurementsThe 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 resultsAnalysis 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. ConclusionsIntraoperative sodium oxybate infusion improved post-operative sleep in patients who underwent gynecological laparoscopic surgery.Trial registration.Chinese Clinical Trial Registry, Clinical trial number: ChiCTR2200061460.