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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Residual Neuromuscular Block; Neuromuscular Blockade Monitoring
• Intervention / Treatment: Diagnostic test: Neuromuscular monitoring; Other: reverse of NMB with sugammadex; Other: reverse of NMB with Sugammadex and neostigmin low dose; Other: reverse of NMB with Sugammadex and neostigmin high dose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aysun Postacı; Phone Number: +9005323520383; Email: aysunposta@yahoo.com
• Study Contact Backup: Name: Rıdvan Durgut; Phone Number: +90 05532316058; Email: ridvandurgut35rd@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group S; Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.	Diagnostic test: Neuromuscular monitoring; TOF monitoring; Other: reverse of NMB with sugammadex; Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.
ACTIVE_COMPARATOR: Group SN1; Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.	Diagnostic test: Neuromuscular monitoring; TOF monitoring; Other: reverse of NMB with Sugammadex and neostigmin low dose; Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg
ACTIVE_COMPARATOR: Grup SN2; Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.	Diagnostic test: Neuromuscular monitoring; TOF monitoring; Other: reverse of NMB with Sugammadex and neostigmin high dose; patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual curarization rate	Pecents of Patients TOFR<0.9	through study completion an average of 3 months
SPO2	peripheric oxygen saturation	through study completion an average of 3 months
MAP	Mean arterial pressure	through study completion an average of 3 months
HR	Heart Rate	through study completion an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV	Postoperative nausea and vomiting	through study completion an average of 3 months
Time to Return of bowel movements	when patients' bowel movements return	through study completion an average of 3 months

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Aysun Postacı, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (ACTUAL): February 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; Postoperative Complications; Rocuronium; Sugammadex; Neostigmine; Delayed Emergence from Anesthesia; Neuromuscular Blockade Monitoring; Residual Neuromuscular Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: E1-21-1914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No