PONVNCT06901596
Sugammadex Reduces Antiemetic Effect of Dexamethasone
An observational study of PONV, run by Augusta University.
Trial summary
Sugammadex is a medication used for reversal of muscle relaxation during procedures under general anesthesia. It works by encapsulating muscle relaxant molecules with a steroid ring in its structure. On the other hand, postoporative nause and vomiting (PONV) is an adverse outcome during anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PONV
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 15 Jul 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult surgical patients scheduled for elective surgery
Who may be able to join
- Older than 18 years old
- Elective surgery
- ASA 1, 2, 3
- At least one risk factor for PONV
Who cannot join
- Pregnancy
- Receiving antiemetics prior to arrival to preoperative holding area
- Receiving opioids prior to arrival to preoperative holding area
- Admission to ICU
- Altered mental status
- Rapid sequence induction
- Nausea or vomiting before surgery
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
Sugammadex is a medication used for reversal of muscle relaxation during procedures under general anesthesia. It works by encapsulating muscle relaxant molecules with a steroid ring in its structure. On the other hand, postoporative nause and vomiting (PONV) is an adverse outcome during anesthesia. PONV can be prevented with pharmacologic agents such as ondansetron and dexamethasone. Dexamethasone is a steroidal agent that can interact with sugammadex. In theory, this interaction could lead to reduced effectiveness of sugammadex. In fact, several studies have explored this interaction. However, the effect of sugammadex on the antiemetic effect of dexamethasone has not been evaluated. This study intends to evaluate this interaction.
Read the detailed description
The study will use de-identified retrospective data to conduct a cross-sectional study to determine the effect of sugammadex on the antiemetic efficacy of dexamethasone in elective adult surgical patients who underwent surgery in a tertiary care center between January 1 2023 and January 1 2024 . The investigators will conduct univariate and multivariate analysis to assess the effect.
- Conditions
- PONV
- Keywords
- sugammadex, dexamethasone, PONV, perioperative, surgery
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Surgical patients who received dexamethasone as prophylactic antiemetic | |
| Dexamethasone + sugammadex | Patients who received dexamethasone intraoperatively and sugammadex to reverse muscle relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PONV
Number of events of PONV during 2 hours after admission to PACU
Measured: 2 hours after admission to PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PONVStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901596
- Sponsor's protocol ID
- 2204574
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are de-identified. The data used for data analysis can be available upon request
Publications
Park HY, Choi HR, Kim YB, Oh SK, Kim T, Yang HS, In J. Chronic exposure to dexamethasone may not affect sugammadex reversal of rocuronium-induced neuromuscular blockade: an in vivo study on rats. Anesth Pain Med (Seoul). 2023 Jul;18(3):275-283. doi: 10.17085/apm.23021. Epub 2023 Jul 14.
PubMed 37468197Choi H, Park SY, Kim YB, In J, Yang HS, Lee JS, Kim S, Park S. Effects of dexamethasone and hydrocortisone on rocuroniuminduced neuromuscular blockade and reversal by sugammadex in phrenic nerve-hemidiaphragm rat model. Korean J Anesthesiol. 2019 Aug;72(4):366-374. doi: 10.4097/kja.d.18.00238. Epub 2019 Mar 19.
PubMed 30886132Koo CH, Hwang JY, Min SW, Ryu JH. A Meta-Analysis on the Effect of Dexamethasone on the Sugammadex Reversal of Rocuronium-Induced Neuromuscular Block. J Clin Med. 2020 Apr 24;9(4):1240. doi: 10.3390/jcm9041240.
PubMed 32344687Lim BG, Won YJ, Kim H. The effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia: A systematic review and meta-analysis. Medicine (Baltimore). 2021 Feb 5;100(5):e23992. doi: 10.1097/MD.0000000000023992.
PubMed 33592855Batistaki C, Pandazi A, Kyttari A, Kaminiotis E, Kostopanagiotou G. Is there an interaction between dexamethasone and sugammadex in real clinical conditions? A randomized controlled trial in patients undergoing laparoscopic cholecystectomy. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):215-219. doi: 10.4103/joacp.JOACP_42_17.
PubMed 31303711
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Reduces Antiemetic Effect of Dexamethasone
- ClinicalTrials.gov ID
- NCT06901596
- Acronym / sponsor ID
- 2204574
- Conditions
- PONV
- Keywords
- sugammadex, dexamethasone, PONV, perioperative, surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 30 Mar 2025 (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.
Sugammadex is a medication used for reversal of muscle relaxation during procedures under general anesthesia. It works by encapsulating muscle relaxant molecules with a steroid ring in its structure. On the other hand, postoporative nause and vomiting (PONV) is an adverse outcome during anesthesia. PONV can be prevented with pharmacologic agents such as ondansetron and dexamethasone. Dexamethasone is a steroidal agent that can interact with sugammadex. In theory, this interaction could lead to reduced effectiveness of sugammadex. In fact, several studies have explored this interaction. However, the effect of sugammadex on the antiemetic effect of dexamethasone has not been evaluated. This study intends to evaluate this interaction.
Detailed description
The study will use de-identified retrospective data to conduct a cross-sectional study to determine the effect of sugammadex on the antiemetic efficacy of dexamethasone in elective adult surgical patients who underwent surgery in a tertiary care center between January 1 2023 and January 1 2024 . The investigators will conduct univariate and multivariate analysis to assess the effect.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | – | –Surgical patients who received dexamethasone as prophylactic antiemetic |
| Dexamethasone + sugammadex | – | –Patients who received dexamethasone intraoperatively and sugammadex to reverse muscle relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult surgical patients scheduled for elective surgery
Key inclusion criteria (4 listed)
- Older than 18 years old
- Elective surgery
- ASA 1, 2, 3
- At least one risk factor for PONV
Key exclusion criteria (7 listed)
- Pregnancy
- Receiving antiemetics prior to arrival to preoperative holding area
- Receiving opioids prior to arrival to preoperative holding area
- Admission to ICU
- Altered mental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of PONV
Time frame: 2 hours after admission to PACU
Number of events of PONV during 2 hours after admission to PACU
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 30 Mar 2025.
- Background: PubMed 37468197Park HY, Choi HR, Kim YB, Oh SK, Kim T, Yang HS, In J. Chronic exposure to dexamethasone may not affect sugammadex reversal of rocuronium-induced neuromuscular blockade: an in vivo study on rats. Anesth Pain Med (Seoul). 2023 Jul;18(3):275-283. doi: 10.17085/apm.23021. Epub 2023 Jul 14.
- Background: PubMed 30886132Choi H, Park SY, Kim YB, In J, Yang HS, Lee JS, Kim S, Park S. Effects of dexamethasone and hydrocortisone on rocuroniuminduced neuromuscular blockade and reversal by sugammadex in phrenic nerve-hemidiaphragm rat model. Korean J Anesthesiol. 2019 Aug;72(4):366-374. doi: 10.4097/kja.d.18.00238. Epub 2019 Mar 19.
- Background: PubMed 32344687Koo CH, Hwang JY, Min SW, Ryu JH. A Meta-Analysis on the Effect of Dexamethasone on the Sugammadex Reversal of Rocuronium-Induced Neuromuscular Block. J Clin Med. 2020 Apr 24;9(4):1240. doi: 10.3390/jcm9041240.
- Background: PubMed 33592855Lim BG, Won YJ, Kim H. The effect of dexamethasone on sugammadex reversal of rocuronium-induced neuromuscular blockade in surgical patients undergoing general anesthesia: A systematic review and meta-analysis. Medicine (Baltimore). 2021 Feb 5;100(5):e23992. doi: 10.1097/MD.0000000000023992.
- Background: PubMed 31303711Batistaki C, Pandazi A, Kyttari A, Kaminiotis E, Kostopanagiotou G. Is there an interaction between dexamethasone and sugammadex in real clinical conditions? A randomized controlled trial in patients undergoing laparoscopic cholecystectomy. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):215-219. doi: 10.4103/joacp.JOACP_42_17.
- Individual participant dataSharing planned: No. Data are de-identified. The data used for data analysis can be available upon request
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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?
An observational study of PONV, run by Augusta University.
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 7 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 30 Mar 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Efrain Riveros Perez, MD (7067217361, eriverosperez@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PONV (time frame: 2 hours after admission to PACU). 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 NCT06901596, which also lists 5 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 30 Mar 2025.