NCT06901596

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 19, 2025

Last Update Submit

March 23, 2025

Conditions

Keywords

sugammadexdexamethasonePONVperioperativesurgery

Outcome Measures

Primary Outcomes (1)

  • Rate of PONV

    Number of events of PONV during 2 hours after admission to PACU

    2 hours after admission to PACU

Study Arms (2)

Dexamethasone

Surgical patients who received dexamethasone as prophylactic antiemetic

Dexamethasone + sugammadex

Patients who received dexamethasone intraoperatively and sugammadex to reverse muscle relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult surgical patients scheduled for elective surgery

You may qualify if:

  • Older than 18 years old
  • Elective surgery
  • ASA 1, 2, 3
  • At least one risk factor for PONV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 37468197BACKGROUND
  • 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.

    PMID: 30886132BACKGROUND
  • 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.

    PMID: 32344687BACKGROUND
  • 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.

    PMID: 33592855BACKGROUND
  • 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.

    PMID: 31303711BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Central Study Contacts

Efrain Riveros Perez, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 30, 2025

Study Start

April 1, 2025

Primary Completion

June 30, 2025

Study Completion

July 15, 2025

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Data are de-identified. The data used for data analysis can be available upon request