2.1 Study design and participants
bleeding, blood loss, nausea and vomiting, pain, hypercapnia
BLEEDING, SUBCUTANEOUS EMPHYSEMA, POSTOPERATIVE COMPLICATIONS, BLOOD LOSS, SECONDARY
This prospective, randomized controlled trial has been approved by the Ethics Committee of the First Affiliated Hospital of Zhengzhou University (2021-KY-1097-003). The trial was pre-registered at the Chinese Clinical Trial Registry (ChiCTR2200056823) on February 18, 2022. Written informed consent was obtained from all patients.Ninety-two patients aged from 18 to 65 years, with a BMI of 18–30 kg/mUsing a random number table method, patients were randomly assigned in a 1:1 ratio to esketamine group (K group) and control group (C group). Each patient’s group arrangement was stored in a sealed envelope and opened by the anesthesia nurse who was not involved in the study when the patient entered the operation room. Anesthesiologists were unaware of the patient grouping and administered anesthesia to patients. Patients, surgeons, and postoperative follow-up assessors (the same anesthesiologists) were blinded to the group assignment. Esketamine, 50 mg, was diluted to a total of 50 ml with normal saline solution. Both esketamine and normal saline were drawn into identical 50-ml syringes by the same anesthesia nurse.All patients fasted for 8 hours and were denied water for 4 hours before surgery and peripheral venous access was established before the patients entered the operation room. After patients entered the operation room, peripheral venous access was opened and the electrocardiogram (ECG), non-invasive blood pressure (NBP), heart rate (HR), pulse oxygen saturation (SpOPalonosetron (0.25mg) was injected intravenously to prevent nausea and vomiting, and sufentanil (0.1–0.2 μg/kg) was used for analgesia about 30 minutes before the end of the surgery. All anesthesia maintenance drugs were stopped when the skin was sutured. Following surgery, all patients in both groups received a patient-controlled intravenous analgesia pump (PCIA, 200 ml) containing oxycodone 0.6 mg/kg and palonosetron 0.25 mg for 48 hours. The background infusion rate was 3 ml/h, the single additional dose was 4 ml, the locking time was 15 minutes, and no initial infusion dose was administered. The visual analogue scale (VAS) was used to assess pain intensity; a score of 0 was defined as no pain, and a score of 10 was defined as worst imaginable pain. After the operation, all patients were transferred to the post- anesthesia care unit (PACU). When the VAS score was ≥ 4, oxycodone 0.05–0.1 mg/kg was injected intravenously for rescue analgesia during the stay in PACU. Patients relieved pain after returning to the ward by increasing the number of analgesic pump compressions and additional analgesic drugs.We excluded patients from the study if they were changed to laparotomy, lost to follow-up, the bleeding volume was greater than 500ml, a large amount of subcutaneous emphysema during the operation, or hypercapnia after operation could not be corrected in a short period of time, the surgical procedure was Miles, and severe postoperative complications impacted the quality of postoperative recovery.The primary outcome of this study was the quality of recovery at 24 h after surgery, as measured by the QoR-15 scale. The QoR-15 measures 15 items from five domains of recovery to assess a patient’s overall recovery: physical comfort (5 items), emotional state (4 items), psychological support (2 items), physical independence (2 items), and pain (2 items). Each item is scored from 0 to 10, with 0 indicating no existence and 10 indicating continuous or strong existence; however, the negative indicators were scored in reverse. The overall QoR-15 score ranges from 0 to 150, with higher scores indicating better quality of postoperative recovery. The QoR-15 was assessed at the following three timepoints: before (TThe secondary outcomes were as follows: the duration of surgery, the consumption of remifentanil, the dosage of cisatracurium, the use of vasoactive drugs, blood loss, rescue analgesia during PACU, respiratory recovery time (the time from anesthetic withdrawal to spontaneous breathing), and extubation time (the time from anesthetic withdrawal to extubation); MAP (mean arterial pressure) and HR at before induction (T