Clinical trial NCT05228223: Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block
Official title: Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block Induced by Rocuronium: A Prospective Randomized Cotrolled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Residual Neuromuscular Block
Neuromuscular Blockade Monitoring
Keywords: Sugammadex
Neostigmine
Neuromuscular Blockade Monitoring
Postoperative Nausea and Vomiting
Delayed Emergence from Anesthesia
Postoperative Complications
Rocuronium
Residual Neuromuscular Block
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled double blind study
Primary purpose: SCREENING

Brief summary: In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.

Detailed description: Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents.

In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.

Eligibility criteria: Inclusion Criteria:

* elective general anesthesia
* Female gender
* Between the ages of 18-65

Exclusion Criteria:

* ASA ≥ 3
* Pregnancy
* Contraindication to use of anesthetic drugs
* Kidney failure
* Liver failure
* Heart failure
* BMI \<18 and BMI \> 35 kg/m2
* anticipated difficult airway
* neuromuscular disease
* Use of drugs that impair neuromuscular transmission
* Patients who develop unexpected massive hemorrhage
* Those who do not have the ability to read, understand and sign the consent form
* Refusal of patient

Primary outcomes:
measure: Residual curarization rate
timeFrame: through study completion an average of 3 months
measure: SPO2
timeFrame: through study completion an average of 3 months
measure: MAP
timeFrame: through study completion an average of 3 months
measure: HR
timeFrame: through study completion an average of 3 months
Secondary outcomes:
measure: PONV
timeFrame: through study completion an average of 3 months
measure: Time to Return of bowel movements
timeFrame: through study completion an average of 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Aysun Postacı
role: PRINCIPAL_INVESTIGATOR
References: