Effect of Timing of Dexamethasone Administration During Induction on Postoperative Outcomes: A Triple-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Incidence of Postoperative Nausea and Vomiting (PONV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study employs a triple-blinded design. Participants, care providers, investigators, and outcomes assessors are all blinded to the group assignments to prevent bias. Additionally, the study coordinators and data analysts responsible for interpreting results are also masked to maintain objectivity in data collection and analysis. Randomization is handled by an independent party, and group assignments are concealed until the completion of data analysis.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dexamethasone pre-induction
Participants in this group will receive a single dose of dexamethasone administered intravenously before fentanyl administration during anesthesia induction. This arm assesses the impact of pre-fentanyl dexamethasone on postoperative outcomes, including nausea, pain, glycemic control, and hemodynamic stability.
干预措施: Dexamethasone (Drug)
Dexamethasone post-induction
Participants in this group will receive a single dose of dexamethasone administered intravenously after the muscle relaxant during anesthesia induction. This arm examines the effects of administering dexamethasone post-muscle relaxant on postoperative outcomes, including nausea, pain, glycemic control, and hemodynamic stability.
干预措施: Dexamethasone (Drug)
No Dexamethasone (Control)
Participants in this control group will not receive dexamethasone during anesthesia induction. This group serves as a baseline to compare the outcomes with those receiving dexamethasone at different timing points.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Incidence of Postoperative Nausea and Vomiting (PONV)
时间窗: 24 hours
To assess the frequency and severity of nausea and vomiting within the first 24 hours after surgery using APFEL scale
次要结局
- Postoperative Pain Levels(At 2, 6, 12, and 24 hours postoperatively)
- Glycemic Variation before induction, 2 hours, and Immediate Postoperative Period(Baseline (immediately before induction), 2 hours after induction, and immediately after surgery)
- Hypotension on Induction and during surgery(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(Up to 24 hours postoperatively)
研究者
AABDI Mohammed
Assistant Professor of Anesthesiology and Critical Care
University Abdelmalek Essaadi faculty of medicine and pharmacy Tangier