Neostigmine Versus Sugammadex on Renal Functions

Sugammadex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06081738
• Other study ID #: 2/2023ANSTH49
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Neostigmine
• Sugammadex

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Menoufia University Hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

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