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NCT Number: NCT06685991

Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes

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.

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Key information

Conditions

Postoperative Nausea and Vomiting (PONV) Hyperglycemia Drug Induced Hypotension on Induction Inflammatory Response to Wounding Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Timing of Dexamethasone Administration Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: 24 hours

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

Secondary outcomes

  1. Postoperative Pain Levels

    Time frame: 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.

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

    Time frame: 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

  3. 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.

    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.

  4. Incidence of Postoperative Complications during first 24 postoperative hours

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed AABDI, M.D, Assistant professor

CONTACT

[email protected]

00212667709011

Sponsors and collaborators

Lead sponsor

AABDI Mohammed

Other

Collaborators

  • University Hospital Center Mohammed VI Tangier, Morocco

Registry information

Official study title

Effect of Timing of Dexamethasone Administration During Induction on Postoperative Outcomes: A Triple-Blinded Randomized Controlled Trial

Acronym: TIDE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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