Neostigmine Versus Sugammadex on Renal Functions

NCT ID: NCT06081738

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Sugammadex Neostigmine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Neostigmine Group

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type 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

Sugammadex Group

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

2-4 mg/kg sugammadex intravenously upon the reappearance of a post-tetanic count 1-2 or a second twitch of TOF after the last dose of rocuronium

Interventions

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Neostigmine

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

Intervention Type DRUG

Sugammadex

2-4 mg/kg sugammadex intravenously upon the reappearance of a post-tetanic count 1-2 or a second twitch of TOF after the last dose of rocuronium

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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mostafa saieed fahim mansour

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2/2023ANSTH49

Identifier Type: -

Identifier Source: org_study_id

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