Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes

NCT06685991 | Not Yet Recruiting Phase 4

• 1 other identifier: UHC M6 TANGIER
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Dexamethasone; Timing of Administration; Anesthesia Induction; Randomized Controlled Trial (RCT); Triple-Blinded Study; Induction Protocol; Postoperative outcomes

Outcome Measures

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

  24 hours

Secondary Outcomes (4)

• Postoperative Pain Levels

  At 2, 6, 12, and 24 hours postoperatively

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

  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.

• Incidence of Postoperative Complications during first 24 postoperative hours

  Up to 24 hours postoperatively

Study Arms (3)

Dexamethasone pre-induction

EXPERIMENTAL

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 post-induction

EXPERIMENTAL

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

No Dexamethasone (Control)

PLACEBO COMPARATOR

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

Interventions

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.

Dexamethasone post-induction; Dexamethasone pre-induction; No Dexamethasone (Control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AABDI Mohammed: lead
• University Hospital Center Mohammed VI Tangier, Morocco: collaborator

Related Publications (2)

• 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.

  PMID: 21799397 BACKGROUND

• 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.

  PMID: 11093989 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Mohammed AABDI, M.D, Assistant professor

CONTACT

00212667709011; med.aabdi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employs a triple-blinded design. Participants, care providers, investigators, and outcomes assessors are all blinded to the group assignments to prevent bias. Additionally, the study coordinators and data analysts responsible for interpreting results are also masked to maintain objectivity in data collection and analysis. Randomization is handled by an independent party, and group assignments are concealed until the completion of data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care

Model Details: Participants in this study will be randomly assigned to one of three parallel groups to evaluate the effects of timing of dexamethasone administration during anesthesia induction on postoperative outcomes. Group 1 will receive dexamethasone before fentanyl administration. Group 2 will receive dexamethasone after the muscle relaxant administration. Group 3 (control) will receive no dexamethasone. This parallel assignment model allows for a direct comparison of outcomes across the three groups, examining factors such as postoperative nausea and vomiting, pain, glycemic control, and hemodynamic stability. Randomization and triple-blinding are implemented to minimize bias and improve the reliability of results.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 13, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11