Postoperative Nausea and Vomiting (PONV)Phase 4TIDENCT06685991
Effect of Timing of Dexamethasone During Induction on Postoperative Outcomes
A Phase 4 study testing Dexamethasone in people with Postoperative Nausea and Vomiting (PONV) and Postoperative Pain, run by AABDI Mohammed.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV), Postoperative Pain, Inflammatory Response to Wounding
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting (PONV), Postoperative Pain, Inflammatory Response to Wounding, Hyperglycemia Drug Induced, Hypotension on Induction, Timing of Dexamethasone Administration
- Being tested
- Dexamethasone
- Keywords
- Dexamethasone, Timing of Administration, Anesthesia Induction, Randomized Controlled Trial (RCT), Triple-Blinded Study, Induction Protocol, Postoperative outcomes
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and Vomiting (PONV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AABDI Mohammed
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center Mohammed VI Tangier, Morocco
- Responsible party
- Sponsor-investigator, AABDI Mohammed, University Abdelmalek Essaadi faculty of medicine and pharmacy Tangier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685991
- Sponsor's protocol ID
- UHC M6 TANGIER
- Acronym
- TIDE
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 21799397Wang 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.
PubMed 11093989
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of Dexamethasone Administration During Induction on Postoperative Outcomes: A Triple-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06685991
- Acronym / sponsor ID
- TIDE / UHC M6 TANGIER
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AABDI MohammedUniversity, hospital or other
- Collaborators
- University Hospital Center Mohammed VI Tangier, Morocco
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone pre-induction | Experimental | Drug: DexamethasoneParticipants 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 | Experimental | Drug: DexamethasoneParticipants 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) | Placebo comparator | Drug: DexamethasoneParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone 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. | Drug | Dexamethasone post-induction, Dexamethasone pre-induction, No Dexamethasone (Control) |
Primary outcome
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
4 secondary outcomes
Postoperative Pain Levels
Time frame: At 2, 6, 12, and 24 hours postoperatively
Glycemic Variation before induction, 2 hours, and Immediate Postoperative Period
Time frame: Baseline (immediately before induction), 2 hours after induction, and immediately after surgery
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.
Incidence of Postoperative Complications during first 24 postoperative hours
Time frame: Up to 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Background: PubMed 21799397De 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.
- Background: PubMed 11093989Wang 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Postoperative Nausea and Vomiting (PONV) and Postoperative Pain, run by AABDI Mohammed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed AABDI, M.D, Assistant professor (00212667709011, med.aabdi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Nausea and Vomiting (PONV) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06685991, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.