Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone.
- Who it may be relevant to
- Registry conditions: Postoperative Nausea and Vomiting (PONV), Postoperative Pain, Inflammatory Response to Wounding, Hyperglycemia Drug Induced. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Timing of Dexamethasone Administration During Induction on Postoperative Outcomes: A Triple-Blinded Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Drug 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
Primary outcome measures
- Incidence of Postoperative Nausea and Vomiting (PONV) [Time frame: 24 hours]
Secondary outcome measures (4)
- Postoperative Pain Levels [Time frame: At 2, 6, 12, and 24 hours postoperatively]
- Glycemic Variation before induction, 2 hours, and Immediate Postoperative Period [Time frame: Baseline (immediately before induction), 2 hours after induction, and immediately after surgery]
- Hypotension on Induction and during surgery [Time frame: 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 [Time frame: Up to 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT06685991 · UHC M6 TANGIER