Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes

Официальное название

Effect of Timing of Dexamethasone Administration During Induction on Postoperative Outcomes: A Triple-Blinded Randomized Controlled Trial

Обзор

This study aims to investigate how the timing of dexamethasone administration during anesthesia induction affects patient outcomes after surgery. Dexamethasone is commonly used to reduce nausea and inflammation during and after surgery. However, it is not yet known if administering dexamethasone at different times during induction (before, during, or after specific anesthetic drugs) leads to better recovery and fewer postoperative complications. Participants will be randomly assigned to one of three groups: one group will receive dexamethasone before fentanyl, another after the muscle relaxant, and a third group will not receive dexamethasone. This approach will help us understand if the timing of dexamethasone affects patient outcomes such as nausea, pain, and recovery quality. The study is triple-blinded, meaning that the participants, care providers, and investigators will not know which group the participants are in, to ensure unbiased results.

Подробное описание

This study explores the effects of different timings of dexamethasone administration during the induction phase of anesthesia on various postoperative outcomes. Dexamethasone is widely used in anesthesia practice to prevent postoperative nausea and vomiting (PONV) and to reduce inflammatory responses. However, the optimal timing of its administration has not been conclusively established, which may impact its effectiveness and patient recovery.

In this triple-blind randomized controlled trial, participants will be assigned to one of three intervention groups to receive dexamethasone at different times during anesthesia induction: (1) prior to fentanyl administration, (2) after administration of a muscle relaxant, or (3) no dexamethasone as a control group. We hypothesize that the timing of dexamethasone administration may influence outcomes such as incidence and severity of PONV, pain levels, time to recovery, and other potential complications.

By analyzing these parameters, the study seeks to establish an evidence-based guideline for the timing of dexamethasone administration to optimize postoperative recovery. The findings could inform anesthetic protocols and enhance patient outcomes in surgical settings.

Вмешательства

• Препарат Dexamethasone
  Dexamethasone will be administered intravenously at varying times during anesthesia induction to assess the impact of timing on postoperative outcomes. Participants will be randomized into one of three groups: one group will receive dexamethasone before the administration of fentanyl, a second group will receive it after the administration of a muscle relaxant, and a third control group will not receive dexamethasone. This timing variation aims to determine the optimal administration point to im

Первичные конечные точки

• Incidence of Postoperative Nausea and Vomiting (PONV) [Срок оценки: 24 hours]

Вторичные конечные точки (4)

• Postoperative Pain Levels [Срок оценки: At 2, 6, 12, and 24 hours postoperatively]
• Glycemic Variation before induction, 2 hours, and Immediate Postoperative Period [Срок оценки: Baseline (immediately before induction), 2 hours after induction, and immediately after surgery]
• Hypotension on Induction and during surgery [Срок оценки: Record blood pressure at baseline (pre-induction), every 5 minutes during the induction period, and at the end of induction to evaluate stability.]
• Incidence of Postoperative Complications during first 24 postoperative hours [Срок оценки: Up to 24 hours postoperatively]

Критерии участия

Критерии включения

• Adults aged 18 years or older
• Scheduled for elective non cardiac surgery requiring general anesthesia
• surgery last at least 90 minutes
• scare of more than 5 cm Able to provide informed consent Eligible for dexamethasone administration as part of routine perioperative care

Критерии исключения

• Known allergy or hypersensitivity to dexamethasone or related corticosteroids
• History of uncontrolled diabetes mellitus or significant blood glucose management issues, as dexamethasone may affect glucose levels
• Severe cardiovascular instability or hemodynamic issues contraindicating study participation
• Patients receiving immunosuppressive therapy or with conditions affecting the immune system, as corticosteroids may alter immune responses
• Pregnancy or breastfeeding, due to potential risks to the fetus or infant
• Current or recent (within 30 days) use of other glucocorticoids, which may interfere with study outcomes
• Patients with psychiatric or cognitive conditions that impair their ability to consent or adhere to study protocols
• Lack of informed consent

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2. PMID 21799397
• Wang JJ, Ho ST, Lee SC, Liu YC, Ho CM. The use of dexamethasone for preventing postoperative nausea and vomiting in females undergoing thyroidectomy: a dose-ranging study. Anesth Analg. 2000 Dec;91(6):1404-7. doi: 10.1097/00000539-200012000-00019. PMID 11093989

Идентификаторы

NCT: NCT06685991 · UHC M6 TANGIER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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