Lean Body Weight-adjusted Rocuronium Dose and Intubation Conditions

NCT ID: NCT05476952

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2023-04-01

Brief Summary

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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..

Detailed Description

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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%.

Conditions

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Body Weight Changes Rocuronium Intubation Conditions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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".

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".

Intervention Type PROCEDURE

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.

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".

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".

Intervention Type PROCEDURE

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.

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".

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".

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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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".

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role collaborator

DUYGU DEMİROZ

OTHER

Sponsor Role lead

Responsible Party

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DUYGU DEMİROZ

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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duygu demiröz

Role: STUDY_DIRECTOR

INONU UNİVERSİTY

Locations

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Inonu universitesi

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30507268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33906465 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36263238 (View on PubMed)

Other Identifiers

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Inonu universty OF MEDİCİNE

Identifier Type: -

Identifier Source: org_study_id

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