Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAABDI Mohammed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Dexamethasone pre-inductionExperimental treatment 1 intervention
Group B: Dexamethasone post-inductionExperimental treatment 1 intervention
Group C: No Dexamethasone (Control)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Nausea and Vomiting (PONV)

To assess the frequency and severity of nausea and vomiting within the first 24 hours after surgery using APFEL scale

Time frame
24 hours

Secondary outcomes

1

Postoperative Pain Levels

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.

Time frame
At 2, 6, 12, and 24 hours postoperatively
2

Glycemic Variation before induction, 2 hours, and Immediate Postoperative Period

Evaluate blood glucose levels at baseline Baseline (immediately before induction), 2 hours after induction, and immediately after surgery

Time frame
Baseline (immediately before induction), 2 hours after induction, and immediately after surgery
3

Hypotension on Induction and during surgery

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.

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.
4

Incidence of Postoperative Complications during first 24 postoperative hours

Record any adverse events or complications that occur within the first 24 hours postoperatively, such as infections, respiratory issues, or other related complications.

Time frame
Up to 24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AABDI Mohammed

Lead sponsor

University Abdelmalek Essaadi faculty of medicine and pharmacy Tangier

Sponsor institution

University Hospital Center Mohammed VI Tangier, Morocco

Collaborator

This trial is not recruiting at the moment. You can still explore other options: