NCT06081738

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

September 23, 2023

Last Update Submit

October 10, 2023

Conditions

SugammadexNeostigmine

Outcome Measures

Primary Outcomes (1)

  • neutrophil gelatinase associated lipocalin (NGAL) values

    normal overall unisex value 47-55 ng/ml

    baseline ( 2 days preoperative) and 12 hours after surgery

Study Arms (2)

Neostigmine Group

ACTIVE COMPARATOR
Drug: Neostigmine

Sugammadex Group

ACTIVE COMPARATOR
Drug: Sugammadex

Interventions

NeostigmineDRUG

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
SugammadexDRUG

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

Sugammadex Group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, 32513, Egypt

Location

MeSH Terms

Interventions

NeostigmineSugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 23, 2023

First Posted

October 13, 2023

Study Start

March 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 31, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)