Annals of medicine · 2025
Effects of esketamine infusion on tourniquet-induced hypertension in patients undergoing below-knee orthopedic surgery: protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Jiang Kai, Zhao Wen-Qian, Ying Yao-Yu, Zhuang Min-Yuan, Shi Hai-Jing, Ji Fu-Hai, Peng Ke
Аннотация
INTRODUCTION: Application of a tourniquet reduces surgical bleeding while causing pain and tourniquet-induced hypertension (TIH). Deeper anesthesia and additional opioids are often insufficient to mitigate TIH but are associated with prolonged recovery and complications. Herein, we describe the protocol for a clinical trial investigating whether intraoperative esketamine infusion would reduce the rate of TIH during below-knee orthopedic surgery.
PATIENTS AND METHODS: This prospective, randomized, double-blind, controlled trial will include a total of 80 adults scheduled for below-knee orthopedic surgery under general anesthesia. Patients will be randomly assigned in a 1:1 ratio to receive either esketamine infusion at 0.25 mg/kg/h or normal saline infusion after anesthesia induction and during tourniquet inflation. Both groups will receive ultrasound-guided unilateral popliteal sciatic nerve block and adductor canal block with 0.25% ropivacaine. The primary outcome is the occurrence of TIH, defined as an increase in systolic blood pressure >30% of baseline during tourniquet inflation. Secondary outcomes include the incidence of hypotension during surgery; intraoperative hemodynamic changes; intraoperative opioid dose and total amount of esmolol; postoperative nausea and vomiting, dizziness, and mental side effects; postoperative pain at 1, 6, 12, and 48 h after surgery; postoperative analgesic consumption within 48 h after surgery; and length of postoperative hospital stay. Additionally, we will assess patients' quality of recovery at 24 h after surgery.
DISCUSSION: This trial will determine the effects of esketamine infusion on TIH in patients who undergo below-knee orthopedic surgery under general anesthesia. Our results will offer a new insight into optimizing anesthetic care for surgical patients receiving tourniquet.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2400081237).
PATIENTS AND METHODS: This prospective, randomized, double-blind, controlled trial will include a total of 80 adults scheduled for below-knee orthopedic surgery under general anesthesia. Patients will be randomly assigned in a 1:1 ratio to receive either esketamine infusion at 0.25 mg/kg/h or normal saline infusion after anesthesia induction and during tourniquet inflation. Both groups will receive ultrasound-guided unilateral popliteal sciatic nerve block and adductor canal block with 0.25% ropivacaine. The primary outcome is the occurrence of TIH, defined as an increase in systolic blood pressure >30% of baseline during tourniquet inflation. Secondary outcomes include the incidence of hypotension during surgery; intraoperative hemodynamic changes; intraoperative opioid dose and total amount of esmolol; postoperative nausea and vomiting, dizziness, and mental side effects; postoperative pain at 1, 6, 12, and 48 h after surgery; postoperative analgesic consumption within 48 h after surgery; and length of postoperative hospital stay. Additionally, we will assess patients' quality of recovery at 24 h after surgery.
DISCUSSION: This trial will determine the effects of esketamine infusion on TIH in patients who undergo below-knee orthopedic surgery under general anesthesia. Our results will offer a new insight into optimizing anesthetic care for surgical patients receiving tourniquet.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2400081237).