Lean Body Weight-adjusted Rocuronium Dose and Intubation Conditions (LBW)

September 27, 2023 updated by: DUYGU DEMİROZ

The Effect of Lean Body Weight-adjusted Rocuronium Dose on Intubation Conditions: a Prospective Observational Study

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..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The whole body will be routinely monitored with electrocardiogram, oximetry oximetry, and non-invasive arterial monitoring. For anesthesia induction, intravenous (IV) fentanyl 50-100 µg and propofol 2mg/kg will be ventilated 100% by lightning. After optimal general anesthesia was achieved, the ulnar nerve was adapted and monitored at the wrist with TOF-Watch® SX (Organon, Swords Co., Dublin, Ireland). LBW lower content of 0.6 mg/kg rocuronium will be administered. K subgrade similar a dose based on TBW will be administered. The time to duration of rocuronium TOF responses will be measured (T1 (seconds)). All consumers will be intubated with a Macintosh laryngoscope diameter with endotracheal sold with inner tubes of 7.5 8.0 mm and 7 mm to 7.5 mm. A single air anesthetist will evaluate the intubation target according to the Han-Raulo intubation scoreboard. Anesthesia will be provided with sevoflurane and an additional dose of phenyl. Monitoring with TOF was continued until the initial fasciculation power (T2=min) of the adductor pollicis decreased to 25% and was approached to an additional rocuronium dose of 0.3mg/kg. All anesthetic agents for operation will be discontinued and extubated when the TOF value reaches 90%.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 44050
        • Inonu universitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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".
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.
Other Names:
  • 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 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".
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.
Other Names:
  • 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 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".
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.
Other Names:
  • 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate intubation conditions with LBW adjusted rocuronium dose .
Time Frame: 3 mount
MAINTAINING SUFFICIENT INTUBATION CONDITIONS WITH LOW DOSE ROCURONIUM
3 mount

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DUYGU DEMİROZ

Collaborators

Inonu University

Investigators

  • Study Director: duygu demiröz, Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

March 18, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inonu universty OF MEDİCİNE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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