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

Primary Purpose

Residual Neuromuscular Block, Neuromuscular Blockade Monitoring

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular monitoring
reverse of NMB with sugammadex
reverse of NMB with Sugammadex and neostigmin low dose
reverse of NMB with Sugammadex and neostigmin high dose
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Residual Neuromuscular Block focused on measuring Sugammadex, Neostigmine, Neuromuscular Blockade Monitoring, Postoperative Nausea and Vomiting, Delayed Emergence from Anesthesia, Postoperative Complications, Rocuronium, Residual Neuromuscular Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group S

Group SN1

Grup SN2

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Residual curarization rate
Pecents of Patients TOFR<0.9
SPO2
peripheric oxygen saturation
MAP
Mean arterial pressure
HR
Heart Rate

Secondary Outcome Measures

PONV
Postoperative nausea and vomiting
Time to Return of bowel movements
when patients' bowel movements return

Full Information

First Posted
September 19, 2021
Last Updated
January 27, 2022
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT05228223
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled double blind study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group S
Arm Type
Active Comparator
Arm Description
Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.
Arm Title
Group SN1
Arm Type
Active Comparator
Arm Description
Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.
Arm Title
Grup SN2
Arm Type
Active Comparator
Arm Description
Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.
Intervention Type
Diagnostic Test
Intervention Name(s)
Neuromuscular monitoring
Intervention Description
TOF monitoring
Intervention Type
Other
Intervention Name(s)
reverse of NMB with sugammadex
Intervention Description
Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.
Intervention Type
Other
Intervention Name(s)
reverse of NMB with Sugammadex and neostigmin low dose
Intervention Description
Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg
Intervention Type
Other
Intervention Name(s)
reverse of NMB with Sugammadex and neostigmin high dose
Intervention Description
patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg
Primary Outcome Measure Information:
Title
Residual curarization rate
Description
Pecents of Patients TOFR<0.9
Time Frame
through study completion an average of 3 months
Title
SPO2
Description
peripheric oxygen saturation
Time Frame
through study completion an average of 3 months
Title
MAP
Description
Mean arterial pressure
Time Frame
through study completion an average of 3 months
Title
HR
Description
Heart Rate
Time Frame
through study completion an average of 3 months
Secondary Outcome Measure Information:
Title
PONV
Description
Postoperative nausea and vomiting
Time Frame
through study completion an average of 3 months
Title
Time to Return of bowel movements
Description
when patients' bowel movements return
Time Frame
through study completion an average of 3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysun Postacı
Phone
+9005323520383
Email
aysunposta@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rıdvan Durgut
Phone
+90 05532316058
Email
ridvandurgut35rd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysun Postacı
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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