Hyperglycemia Drug Induced, Hypotension on Induction, Inflammatory Response to Wounding, Postoperative Nausea and Vomiting (PONV), Postoperative Pain, Timing of Dexamethasone Administration
Conditions
Keywords
Dexamethasone, Timing of Administration, Anesthesia Induction, Randomized Controlled Trial (RCT), Triple-Blinded Study, Induction Protocol, Postoperative outcomes
Brief summary
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
DRUGDexamethasone
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 improve outcomes, including postoperative nausea, pain, glycemic stability, and hemodynamic response.
Sponsors
University Hospital Center Mohammed VI Tangier, Morocco
AABDI Mohammed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants in this study will be randomly assigned to one of three parallel groups to evaluate the effects of timing of dexamethasone administration during anesthesia induction on postoperative outcomes. Group 1 will receive dexamethasone before fentanyl administration. Group 2 will receive dexamethasone after the muscle relaxant administration. Group 3 (control) will receive no dexamethasone. This parallel assignment model allows for a direct comparison of outcomes across the three groups, examining factors such as postoperative nausea and vomiting, pain, glycemic control, and hemodynamic stability. Randomization and triple-blinding are implemented to minimize bias and improve the reliability of results.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting (PONV) | 24 hours | To assess the frequency and severity of nausea and vomiting within the first 24 hours after surgery using APFEL scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Levels | At 2, 6, 12, and 24 hours postoperatively | The Visual Analog Scale (VAS) ranges from 0 to 10, where 0 represents no pain and 10 represents worst possible pain. Higher scores indicate greater pain intensity, representing a worse outcome. |
| Glycemic Variation before induction, 2 hours, and Immediate Postoperative Period | Baseline (immediately before induction), 2 hours after induction, and immediately after surgery | Evaluate blood glucose levels at baseline 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. | Record events of hypotension defined my mean arterial pressure (MAP) \<65 mmHg or systolic arterial pressure (SAP) \<90 mmHg or a drop by \> 30% of baseline MAP or SAP. |
| Incidence of Postoperative Complications during first 24 postoperative hours | Up to 24 hours postoperatively | Record any adverse events or complications that occur within the first 24 hours postoperatively, such as infections, respiratory issues, or other related complications. |
Contacts
Primary ContactMohammed AABDI, M.D, Assistant professor
Outcome results
None listed