Effects of mini-dose esketamine–dexmedetomidine combination supplemented intravenous analgesia on postoperative sleep quality in elderly patients after total knee arthroplasty: a protocol of double-blind randomised trial
Bibliographic record
Abstract
INTRODUCTION: Postoperative sleep quality is generally impaired in elderly patients undergoing total knee arthroplasty. Decreased postoperative sleep quality seriously affects postoperative recovery. Both esketamine and dexmedetomidine have been individually demonstrated to have the potential to enhance postoperative sleep quality. However, the effectiveness of mini-dose esketamine-dexmedetomidine supplemented intravenous analgesia on postoperative sleep quality remains to be elucidated. METHODS AND ANALYSIS: 110 elderly patients undergoing total knee arthroplasty will be randomly assigned to different regimens of patient-controlled intravenous analgesia with a total volume of 100 mL in either the experimental group (sufentanil 1.5 µg/kg+esketamine 25 mg+dexmedetomidine 100 µg) or the control group (sufentanil 1.5 µg/kg+equal vol of placebo, ie, saline). The primary outcome is the subjective sleep quality score on the night of surgery, assessed using the Richards-Campbell Sleep Questionnaire. The secondary outcomes are the Richards-Campbell Sleep Questionnaire scores on the first and second postoperative nights. Patients' pain scores, Richmond Agitation-Sedation Scale scores, analgesic medication usage and incidence of nausea and vomiting are documented two times per day for two postoperative days. The Montreal Cognitive Assessment score is assessed on the day of discharge. Regarding other outcomes, telephone follow-up will be performed at 30 days postoperatively to assess the Pittsburgh Sleep Quality Index score and identify and document major complications within 30 days. Safety outcomes encompass not only the monitoring of basic vital signs such as hypotension, hypertension, tachycardia, bradycardia and low peripheral oxygen saturation but also psychiatric symptoms, including nightmares, hallucinations, restlessness, confusion, diplopia and blurred vision. The analysis will be conducted according to the principle of intention-to-treat. ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Research Ethics Committee of Weifang People's Hospital (KYLL20240523-1). The results of the study will be published in peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: ChiCTR2400085253.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.007 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.013 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".