Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block

Neuromuscular Blockade Monitoring Clinical Trial

Official title:

Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block Induced by Rocuronium: A Prospective Randomized Cotrolled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05228223
• Other study ID #: E1-21-1914
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 2022

Study information

• Verified date: January 2022
• Source: Ankara City Hospital Bilkent
• Contact: Aysun Postaci
• Phone: +9005323520383
• Email: aysunposta[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade Monitoring
• Residual Neuromuscular Block

Intervention

Diagnostic Test:
• Neuromuscular monitoring
TOF monitoring

Other:
• reverse of NMB with sugammadex
Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.
• reverse of NMB with Sugammadex and neostigmin low dose
Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg
• reverse of NMB with Sugammadex and neostigmin high dose
patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual curarization rate	Pecents of Patients TOFR<0.9	through study completion an average of 3 months
Primary	SPO2	peripheric oxygen saturation	through study completion an average of 3 months
Primary	MAP	Mean arterial pressure	through study completion an average of 3 months
Primary	HR	Heart Rate	through study completion an average of 3 months
Secondary	PONV	Postoperative nausea and vomiting	through study completion an average of 3 months
Secondary	Time to Return of bowel movements	when patients' bowel movements return	through study completion an average of 3 months