NCT05476952

Brief Summary

In this study, researchers wiil administer rocuronium, based on either the lean body weight or the total body weight in patients with body mass index (BMI) of 18.5 to 34.9 and compared the duration of action of the drug and its effects on tracheal intubation conditions and hemodynamic parameters..

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

July 25, 2022

Last Update Submit

September 27, 2023

Conditions

Keywords

the lean body weight, rocuronium, intubation conditions

Outcome Measures

Primary Outcomes (1)

  • To evaluate intubation conditions with LBW adjusted rocuronium dose .

    MAINTAINING SUFFICIENT INTUBATION CONDITIONS WITH LOW DOSE ROCURONIUM

    3 mount

Study Arms (3)

Group 1

Patients with a normal weight between 18.5 and 24.9 BMI Groups will be divided into 2 groups by their own luck. According to DDA, rocuronium will be evaluated as "DDA", and group numbers given according to TBW will be evaluated as "K".

Procedure: he patients who are administered rocuronium according to LBW were categorized as "LBW", and The group number for those administer according to TBW was categorized as "K".

Group 2

overweight patients with a BMI between 25-29.9 Groups will be divided into 2 groups by their own luck. According to DDA, rocuronium will be evaluated as "DDA", and group numbers given according to TBW will be evaluated as "K".

Procedure: he patients who are administered rocuronium according to LBW were categorized as "LBW", and The group number for those administer according to TBW was categorized as "K".

Group 3

patients with a BMI of 30-34.9 in obesity class 1 Groups will be divided into 2 groups by their own luck. According to DDA, rocuronium will be evaluated as "DDA", and group numbers given according to TBW will be evaluated as "K".

Procedure: he patients who are administered rocuronium according to LBW were categorized as "LBW", and The group number for those administer according to TBW was categorized as "K".

Interventions

Patients will be divided equally and validly by the one who will be placed in opaque sealed envelopes on a self-paid basis. One group will be given 0.6 mg/kg rocuronium on an LBW basis (Curon ® 50 mg/5 mL \[Mustafa Nevzat, Istanbul, Turkey\]), and the other group will be given 0.6 mg/kg rocuronium on a TBW basis.

Also known as: Groups will be divided into 2 groups by their own luck. According to DDA, rocuronium will be evaluated as "DDA", and group numbers given according to TBW will be evaluated as "K".
Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18-65 years, with ASA (American Society of Anesthesiologists physical status) ≤ II

You may qualify if:

  • Patients who will receive general anesthesia Operations that will take less than 6 hours Patients to be provided with rocuronium neuromuscular blockade

You may not qualify if:

  • Renal, hepatic, neuromuscular, and metabolic diseases Craniotomies, cardiac, thoracic, and large vessel surgeries Those who did not want to participate in the study will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu universitesi

Malatya, 44050, Turkey (Türkiye)

Location

Related Publications (3)

  • Vasold KL, Parks AC, Phelan DML, Pontifex MB, Pivarnik JM. Reliability and Validity of Commercially Available Low-Cost Bioelectrical Impedance Analysis. Int J Sport Nutr Exerc Metab. 2019 Jul 1;29(4):406-410. doi: 10.1123/ijsnem.2018-0283.

    PMID: 30507268BACKGROUND
  • Erstad BL, Barletta JF. Dosing of neuromuscular blocking agents in patients with obesity: A narrative review. Anaesth Intensive Care. 2021 Mar;49(2):98-104. doi: 10.1177/0310057X20968573. Epub 2021 Apr 27.

    PMID: 33906465BACKGROUND
  • Demiroz D, Colak YZ, Iclek SK, Erdogan MA, Yagci NA, Durmus M, Gulhas N. Does Rocuroinum Dose Adjusted Due to Lean Body Weight Provide Adequate Intubation Conditions?: A Prospective Observational Study. Int J Clin Pract. 2022 Oct 5;2022:6840960. doi: 10.1155/2022/6840960. eCollection 2022.

MeSH Terms

Conditions

Body Weight Changes

Interventions

bis(p-chlorophenyl)acetic acid

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • duygu demiröz

    INONU UNİVERSİTY

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 27, 2022

Study Start

January 30, 2023

Primary Completion

March 18, 2023

Study Completion

April 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations