Comparison of the Effects of Moderate- and High-Dose Glucocorticoids on Postoperative Recovery

Официальное название

Comparison of the Effects of Moderate- and High-Dose Glucocorticoid Administration on Postoperative Recovery: A Prospective Randomized Controlled Trial

Обзор

Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure; however, postoperative pain, nausea, and delayed recovery remain clinically relevant problems. Glucocorticoids such as dexamethasone are widely used in perioperative care for the prevention of postoperative nausea and vomiting and as part of multimodal analgesia strategies. This prospective randomized controlled trial aims to compare the effects of moderate- and high-dose intravenous dexamethasone administered intraoperatively on postoperative recovery in patients undergoing elective laparoscopic cholecystectomy. The primary outcomes include postoperative nausea and vomiting, inflammatory markers (CRP and WBC), and Quality of Recovery-15 (QoR-15) scores. Secondary outcomes include postoperative pain scores, intraoperative remifentanil consumption, postoperative opioid consumption, and adverse events.

Подробное описание

Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures worldwide. Although it is associated with shorter hospital stay and faster recovery compared with open surgery, patients frequently experience postoperative pain, nausea, and delayed functional recovery. Effective perioperative strategies aimed at improving recovery and reducing postoperative complications remain an important component of enhanced recovery protocols.

Glucocorticoids, particularly dexamethasone, are widely used in perioperative care due to their anti-inflammatory, antiemetic, and analgesia-sparing properties. Perioperative dexamethasone administration has been shown to reduce postoperative nausea and vomiting (PONV) and may contribute to improved pain control and overall recovery. However, the optimal dose of dexamethasone for maximizing recovery outcomes while maintaining safety remains unclear.

This prospective randomized controlled study is designed to evaluate whether higher doses of intraoperative dexamethasone provide additional benefits in postoperative recovery compared with moderate doses or placebo in patients undergoing elective laparoscopic cholecystectomy. Patients undergoing elective surgery will be randomly assigned to receive either moderate-dose dexamethasone, high-dose dexamethasone, or placebo as part of perioperative management.

All patients will receive standardized anesthesia management and multimodal analgesia according to institutional practice. Postoperative recovery will be evaluated using patient-reported recovery quality scores, inflammatory markers, and commonly assessed clinical outcomes including postoperative nausea and vomiting, pain intensity, and analgesic requirements.

The findings of this study may help clarify the dose-response relationship of perioperative dexamethasone and provide evidence to guide optimal dosing strategies aimed at improving postoperative recovery after laparoscopic cholecystectomy.

Вмешательства

• Другое Saline (0.9% NaCl)
  Intravenous normal saline 4 mL administered intraoperatively to S group
• Процедура TAP Block
  Oblique subcostal TAP block is administered to all groups
• Препарат moderate dose Dexamethasone
  Intravenous dexamethasone administered intraoperatively at 0.1 mg/kg (D1)
• Препарат High dose dexamethasone
  Intravenous dexamethasone administered intraoperatively at 0.2 mg/kg (D2; maximum 20 mg).

Первичные конечные точки

• Postoperative Nausea and Vomiting (PONV) [Срок оценки: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively]
• CRP [Срок оценки: preoperative and up to 18 hours postoperatively]
• Quality of Recovery (QoR-15 Score) [Срок оценки: 18 hours after surgery]
• wbc [Срок оценки: preoperative and up to 18 hours postoperatively]

Вторичные конечные точки (6)

• Postoperative Pain Intensity (VAS) [Срок оценки: 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 18 hours postoperatively]
• Intraoperative Remifentanil Consumption [Срок оценки: Intraoperative period]
• Postoperative Opioid Consumption [Срок оценки: Up to 18 hours postoperatively]
• Rescue Analgesic Requirement [Срок оценки: Up to 18 hours postoperatively]
• Shoulder Pain [Срок оценки: Up to 18 hours postoperatively]
• Adverse Events [Срок оценки: Intraoperative and up to 10 days postoperatively]

Критерии участия

Критерии включения

• Age between 18 and 65 years
• ASA physical status I-II
• Scheduled for elective laparoscopic cholecystectomy
• Undergoing general anesthesia
• Ability to provide written informed consent

Критерии исключения

• Patients younger than 18 years or older than 65 years
• Known allergy to dexamethasone
• ASA physical status III or higher
• Surgical procedures lasting longer than 120 minutes
• Emergency surgeries
• Pregnant or breastfeeding patients
• Patients with coagulopathy or receiving anticoagulant therapy
• Known allergy to local anesthetics
• Localized infection at the injection site
• Inflammatory bowel disease
• Autoimmune diseses
• Chronic pain conditions
• Ocular herpes simplex infection
• Cushing's disease
• Myasthenia gravis
• Anticipated poor compliance with the study protocol
• Vaccination within the last 14 days
• Use of systemic glucocorticoids or immunosuppressive drugs
• İmpaired renal function (GFR < 30 mL/min)
• Liver cirrhosis
• Congestive heart failure
• Peripheral nerve disorders
• Elective laparoscopic cholecystectomy due to malignancy
• Conversion to open surgery during the operation
• Epilepsy
• Body mass index (BMI) > 30 kg/m²

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation — Ankara

Идентификаторы

NCT: NCT07469332 · E2-25-10587

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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