Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes

Phase 4Not Yet RecruitingNCT06685991

AABDI Mohammed300 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

DexamethasoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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.

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