Type of outcome measures
postoperative pain, itching, nausea and vomiting, nystagmus, pain, cough, dizziness, postoperative adverse reactions, PONV, postoperative respiratory depression
SECONDARY, HALLUCINOSIS, NYSTAGMUS
The primary outcome measure was the ED50 and ED95 of esketamine for preventing early postoperative pain. The visual analogue scale (VAS) was used to measure the pain intensity at the time point of the awakening period (15 min after tracheal extubation) in two groups, which was an 11 cm scale from zero (no pain) to 10 (most severe pain).The secondary outcome measures were demographic data, vital signs, the condition of patients during anesthesia recovery, and postoperative adverse reactions. Demographic data were recorded, including age, gender, body mass index(BMI), ASA classification (I/II), duration of surgery, sufentanil doses, remifentanil doses, and propofol doses(intraoperative maintenance doses). Vital signs (the mean arterial pressure, MAP; heart rate, HR) were tabulated at the time point of T0 (pre-anesthesia, baseline), T1 (skin incision), and T2 (the dissection of the gallbladder off the liver bed by electric knife). There were also several indexes during the anesthesia recovery: awakening time (the time interval from the end of surgery to extubation), VAS score(incisional pain, resting and cough) at 15 min after tracheal extubation, total VAS score(resting and cough) at 15 min after tracheal extubation, Steward score after extubation, numbers requiring rescue analgesia after extubation, numbers requiring antagonize the residual muscle relaxant, and the medication usage conditions (especially narcotics) in PACU. The postoperative adverse reactions included nausea and vomiting (PONV), hallucinosis, dizziness, itching, nystagmus, nightmare, and postoperative respiratory depression.Steward Scale score is usually applied to assess the awakening intensity during the recovery period and mainly includes awake degree, airway patency, and limb mobility. The awake degree is divided into three categories: fully awake (2 points), response to stimulation (1 point), and no response to stimulation (0 point). Airway patency is collapsed into three categories: can cough according to the doctor’s order (2 points), can maintain airway patency without support (1 point), and respiratory tract needs support (0 point). Limb mobility is classified into three categories: limbs can do conscious activities (2 points), limbs can make unconscious activities (1 point), and no movement of limbs (0 point). The patients could be thought to be leaving the recovery room when the overall scores are greater than or equal to 4.