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

NCT05228223 | Unknown

• 1 other identifier: E1-21-1914
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• PONV

  through study completion an average of 3 months

• Time to Return of bowel movements

  through study completion an average of 3 months

Study Arms (3)

Group S

ACTIVE COMPARATOR

Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.

Diagnostic Test: Neuromuscular monitoring; Other: reverse of NMB with sugammadex

Group SN1

ACTIVE COMPARATOR

Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.

Diagnostic Test: Neuromuscular monitoring; Other: reverse of NMB with Sugammadex and neostigmin low dose

Grup SN2

ACTIVE COMPARATOR

Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.

Diagnostic Test: Neuromuscular monitoring; Other: reverse of NMB with Sugammadex and neostigmin high dose

Interventions

Neuromuscular monitoring DIAGNOSTIC_TEST

TOF monitoring

Group S; Group SN1; Grup SN2

reverse of NMB with sugammadex OTHER

Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.

Group S

reverse of NMB with Sugammadex and neostigmin low dose OTHER

Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg

Group SN1

reverse of NMB with Sugammadex and neostigmin high dose OTHER

patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg

Grup SN2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Postaci A, Durgut R, Aytac BG, Ceyhan M. Effect of sugammadex with neostigmine on postoperative bowel function and on recovery of neuromuscular functions: A randomized controlled trial. Medicine (Baltimore). 2024 Sep 13;103(37):e39623. doi: 10.1097/MD.0000000000039623.

  PMID: 39287249 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia; Postoperative Nausea and Vomiting; Postoperative Complications

Interventions

Neuromuscular Monitoring; Sugammadex

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Aysun Postacı

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aysun Postacı

CONTACT

+9005323520383; aysunposta@yahoo.com

Rıdvan Durgut

CONTACT

+90 05532316058; ridvandurgut35rd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled double blind study

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: February 8, 2022
• Study Start: February 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)