Clinical trial NCT06685991: Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes
Official title: Effect of Timing of Dexamethasone Administration During Induction on Postoperative Outcomes: A Triple-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting (PONV)
Postoperative Pain
Inflammatory Response to Wounding
Hyperglycemia Drug Induced
Hypotension on Induction
Timing of Dexamethasone Administration
Keywords: Dexamethasone
Timing of Administration
Anesthesia Induction
Randomized Controlled Trial (RCT)
Triple-Blinded Study
Induction Protocol
Postoperative outcomes
Lead sponsor: University Abdelmalek Essaadi faculty of medicine and pharmacy Tangier
Sponsor class: OTHER
Collaborators: name: University Hospital Center Mohammed VI Tangier, Morocco
First posted: 2024-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative Pain Levels
timeFrame: At 2, 6, 12, and 24 hours postoperatively
measure: Glycemic Variation before induction, 2 hours, and Immediate Postoperative Period
timeFrame: Baseline (immediately before induction), 2 hours after induction, and immediately after surgery
measure: Hypotension on Induction and during surgery
timeFrame: Record blood pressure at baseline (pre-induction), every 5 minutes during the induction period, and at the end of induction to evaluate stability.
measure: Incidence of Postoperative Complications during first 24 postoperative hours
timeFrame: Up to 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.