Neostigmine Versus Sugammadex on Renal Functions

Sponsor

Menoufia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06081738

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sugammadex Neostigmine	Drug: Neostigmine Drug: Sugammadex	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of The Effects of Neostigmine Versus Sugammadex on Renal Functions in Laparoscopic Cholecystecomy A Randomized Controlled Study

Actual Study Start Date :

Mar 1, 2023

Actual Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Neostigmine Group	Drug: 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
Active Comparator: Sugammadex Group	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

Arm

Intervention/Treatment

Active Comparator: Neostigmine Group

Drug: 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

Active Comparator: Sugammadex Group

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menoufia University Hospitals	Shibīn Al Kawm	Menoufia	Egypt	32513

Sponsors and Collaborators

Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mostafa saieed fahim mansour, lecturer, Menoufia University

ClinicalTrials.gov Identifier:

NCT06081738

Other Study ID Numbers:

2/2023ANSTH49

First Posted:

Oct 13, 2023

Last Update Posted:

Oct 13, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Neostigmine

Study Results

No Results Posted as of Oct 13, 2023