Clinical trial NCT06901596: Sugammadex Reduces Antiemetic Effect of Dexamethasone
Official title: Sugammadex Reduces Antiemetic Effect of Dexamethasone
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: PONV
Keywords: sugammadex
dexamethasone
PONV
perioperative
surgery
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult surgical patients scheduled for elective surgery

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of PONV
timeFrame: 2 hours after admission to PACU
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.