Participants
comorbidity, hepatorenal dysfunction, epilepsy, multiple primary malignant tumors, dementia, diabetes, ovarian cyst rupture, gynecologic disease, schizophrenia, gynecological cancer, Cancer
UNCONTROLLED HYPERTENSION, GYNECOLOGIC DISEASES, ENDOMETRIOSIS, HEMOPERITONEUM, PELVIC INFLAMMATORY DISEASE, EPILEPSY, RECRUITMENT, DIABETES, OVARIAN CYST RUPTURE, CHRONIC PAIN, TUMOR RECURRENCE, CANCER
The double-blind, prospective randomized controlled trial was conducted in a tertiary hospital in Beijing, China. This study was approved by the Institutional Review Board at Peking University Cancer Hospital’s Ethics Committee (No.2021YJZ109) and written informed consent was obtained from all subjects participating in the trial. The trial was registered prior to patient enrollment at the Chinese Clinical Trial Registry (No. ChiCTR2200055180, Principal investigator: Hongyu Tan, Date of registration: January 02, 2022). This article adheres to applicable Consolidated Standards of Reporting Trials (CONSORT) guidelines.Eligible patients were recruited at the Peking University Cancer Hospital from January 2022 to July 2022 if they (1) were aged 18–65 years, with body mass index (BMI, in kg/mAll eligible patients were randomly assigned to the S-ketamine group (group S) or placebo (0.9% saline) group (group C) in a 1:1 ratio. The randomization was performed by a data manager who was not involved in determining eligibility or assessment of outcomes. The participants were randomized using random number tables. A research nurse who was independent of the recruitment process opened each patient’s envelope containing the random numbers upon completion of the baseline assessment. Patients with the following conditions were excluded from the study: (1) refusal to participate in the study; (2) tumor recurrence; (3) multiple primary malignant tumors; (4) current and chronic use of analgesics, psychotropic medications, hormones, or non-steroidal anti-inflammatories; (5) a history of chronic pain, schizophrenia, epilepsy, dementia; (6) a history of diabetes with uncontrolled hypertension or blood glucose; (7) hepatorenal dysfunction; (8) any contraindications to the anesthetic agents used during surgery; (9) any of the gynecologic disease such as pelvic inflammatory disease, endometriosis ovarian cyst rupture with hemoperitoneum. The enrolled patients’ age, BMI, ASA physical status, preoperative comorbidity, and type of gynecological cancer were recorded.