Body Weight ChangesLBWNCT05476952
Lean Body Weight-adjusted Rocuronium Dose and Intubation Conditions
An observational study of Body Weight Changes and Rocuronium, run by DUYGU DEMİROZ at 1 site in Turkey (Türkiye).
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Rocuronium, Intubation Conditions
- What is being tested?
- 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".
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-65 years, with ASA (American Society of Anesthesiologists physical status) ≤ II
Who may be able to join
- Patients who will receive general anesthesia Operations that will take less than 6 hours Patients to be provided with rocuronium neuromuscular blockade
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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..
Read the 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%.
- Conditions
- Body Weight Changes, Rocuronium, Intubation Conditions
- Being tested
- 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".
- Keywords
- the lean body weight, rocuronium, intubation conditions
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".Procedure or surgery
Also called 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".
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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". Receives: 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". Receives: 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate intubation conditions with LBW adjusted rocuronium dose .
MAINTAINING SUFFICIENT INTUBATION CONDITIONS WITH LOW DOSE ROCURONIUM
Measured: 3 mount
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start30 Jan 2023
- Primary completion18 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- DUYGU DEMİROZ
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, DUYGU DEMİROZ, Inonu University
- Investigators
- duygu demiröz, Study director, INONU UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476952
- Sponsor's protocol ID
- Inonu universty OF MEDİCİNE
- Acronym
- LBW
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30507268Erstad 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.
PubMed 33906465Demiroz 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.
PubMed 36263238
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lean Body Weight-adjusted Rocuronium Dose on Intubation Conditions: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05476952
- Acronym / sponsor ID
- LBW / Inonu universty OF MEDİCİNE
- Conditions
- Body Weight Changes, Rocuronium, Intubation Conditions
- Keywords
- the lean body weight, rocuronium, intubation conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- DUYGU DEMİROZUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | 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 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". |
| Group 2 | – | 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".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". |
| Group 3 | – | 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 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". |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 years, with ASA (American Society of Anesthesiologists physical status) ≤ II
Key inclusion criteria (1 listed)
- Patients who will receive general anesthesia Operations that will take less than 6 hours Patients to be provided with rocuronium neuromuscular blockade
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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".Also: 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".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. | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
To evaluate intubation conditions with LBW adjusted rocuronium dose .
Time frame: 3 mount
MAINTAINING SUFFICIENT INTUBATION CONDITIONS WITH LOW DOSE ROCURONIUM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 30507268Vasold 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.
- Background: PubMed 33906465Erstad 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.
- Derived from this study: PubMed 36263238Demiroz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
duygu demiröz study director
INONU UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight Changes and Rocuronium, run by DUYGU DEMİROZ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate intubation conditions with LBW adjusted rocuronium dose . (time frame: 3 mount). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05476952, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.