- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06901596
Sugammadex Reduces Antiemetic Effect of Dexamethasone
March 23, 2025 updated by: Efrain Riveros Perez, MD, Augusta University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Efrain Riveros Perez, MD
- Phone Number: 7067217361
- Email: eriverosperez@augusta.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult surgical patients scheduled for elective surgery
Description
Inclusion Criteria:
- Older than 18 years old
- Elective surgery
- ASA 1, 2, 3
- At least one risk factor for PONV
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Dexamethasone
Surgical patients who received dexamethasone as prophylactic antiemetic
|
|
Dexamethasone + sugammadex
Patients who received dexamethasone intraoperatively and sugammadex to reverse muscle relaxation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of PONV
Time Frame: 2 hours after admission to PACU
|
Number of events of PONV during 2 hours after admission to PACU
|
2 hours after admission to PACU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Choi 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.
- Koo 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.
- Lim 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.
- Batistaki 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2025
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
July 15, 2025
Study Registration Dates
First Submitted
March 19, 2025
First Submitted That Met QC Criteria
March 23, 2025
First Posted (Actual)
March 30, 2025
Study Record Updates
Last Update Posted (Actual)
March 30, 2025
Last Update Submitted That Met QC Criteria
March 23, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2204574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data are de-identified.
The data used for data analysis can be available upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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