Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes (TIDE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Hypotension on Induction; Hyperglycemia Drug Induced; Postoperative Nausea and Vomiting (PONV); Inflammatory Response to Wounding; Timing of Dexamethasone Administration
• Intervention / Treatment: Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohammed AABDI, M.D, Assistant professor; Phone Number: 00212667709011; Email: med.aabdi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone pre-induction; 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.	Drug: Dexamethasone; 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.
Experimental: Dexamethasone post-induction; 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.	Drug: Dexamethasone; 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.
Placebo Comparator: No Dexamethasone (Control); 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.	Drug: Dexamethasone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	Up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: AABDI Mohammed
• Collaborators: University Hospital Center Mohammed VI Tangier, Morocco

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Estimated): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Dexamethasone; Randomized Controlled Trial (RCT); Anesthesia Induction; Postoperative outcomes; Timing of Administration; Triple-Blinded Study; Induction Protocol
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Metabolic Diseases; Signs and Symptoms, Digestive; Glucose Metabolism Disorders; Nausea; Hypotension; Vomiting; Postoperative Nausea and Vomiting; Hyperglycemia; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: UHC M6 TANGIER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Currently, there are no plans to share individual participant data (IPD) from this study due to considerations around patient privacy and data confidentiality. Given the sensitive nature of perioperative health data and the need to ensure participant anonymity, data sharing will only be considered if adequate safeguards can be implemented. Additionally, sharing IPD requires comprehensive agreements on data access, use, and security, which are not in place at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No