Neostigmine Versus Sugammadex on Renal Functions | NCT06081738

Studies
Neostigmine Versus Sugammadex on Renal Functions

NCT06081738

Sponsor

Menoufia University

Status

Unknown status

Last Update Posted

Oct 13, 2023Actual

Enrollment

64Actual

Phase

Phase 4

Conditions

Sugammadex
Neostigmine

Interventions

Neostigmine
Sugammadex

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Sep 1, 2023Actual

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Sep 23, 2023

First Submission Date that Met QC Criteria

Oct 10, 2023

First Posted Date

Oct 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2023

Last Update Posted Date

Oct 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will assess the acute effects of sugammadex or neostigmine on renal function as determined with more specific and sensitive tests in laparoscopic cholecystectomy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neostigmine Group	Active Comparator		Drug: Neostigmine
Sugammadex Group	Active Comparator		Drug: Sugammadex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neostigmine	Drug	a combination of 0.04 mg/kg neostigmine with 0.01 mg/kg atropine intravenously at the reappearance of a second twitch of TOF after the last dose of rocuronium	Neostigmine Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neutrophil gelatinase associated lipocalin (NGAL) values	normal overall unisex value 47-55 ng/ml	baseline ( 2 days preoperative) and 12 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal renal function (serum Cr 0.4- 1.4 g/dL)
American Society of Anesthesiologists (ASA) Class I-II

Exclusion Criteria:

Incapacity to consent.
Pre-existing impaired kidney functions.
Severe neuromuscular disease, as: myasthenia gravis & muscular dystrophy.
Intra-operative bleeding
Lengthy operations that exceed 2 hours.
Hemodynamic changes more than 20% of the base line

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Menoufia University Hospitals		Shibīn al Kawm	Menoufia	32513	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009388	Neostigmine
D000077122	Sugammadex

Ancestor Terms

ID	Term
D050338	Phenylammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

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