Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes

Phase 4

Not yet recruiting

• Conditions: Postoperative Nausea and Vomiting (PONV); Postoperative Pain; Inflammatory Response to Wounding; Hyperglycemia Drug Induced; Hypotension on Induction; Timing of Dexamethasone Administration
• Interventions: Drug: Dexamethasone

• Registration Number: NCT06685991
• Lead Sponsor: AABDI Mohammed

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-10
• Last Update Submitted: 2024-11-10
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Study Start: 2024-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone pre-induction	Dexamethasone	Participants in this group will receive a single dose of dexamethasone administered intravenously before fentanyl administration during anesthesia induction. This arm assesses the impact of pre-fentanyl dexamethasone on postoperative outcomes, including nausea, pain, glycemic control, and hemodynamic stability.
Dexamethasone post-induction	Dexamethasone	Participants in this group will receive a single dose of dexamethasone administered intravenously after the muscle relaxant during anesthesia induction. This arm examines the effects of administering dexamethasone post-muscle relaxant on postoperative outcomes, including nausea, pain, glycemic control, and hemodynamic stability.
No Dexamethasone (Control)	Dexamethasone	Participants in this control group will not receive dexamethasone during anesthesia induction. This group serves as a baseline to compare the outcomes with those receiving dexamethasone at different timing points.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.