Rapid Sequence InductionNCT05067829
Rapid Sequence Intubation With Rocuronium in Elderly Patients
A study testing Train of four(TOF) in people with Rapid Sequence Induction and Rapid Sequence Intubation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
With the prolongation of life expectancy, the frequency of surgical intervention and anesthesia increases in elderly patients. The rapid Sequence Intubation(RSI) technique is preferred in patients with aspiration risk and who will undergo general anesthesia, especially in the pandemic period, to reduce or eliminate… Read more about this study
- Who is it for?
- Ages 65 to 100 years, women only
- Conditions the study is for
- Rapid Sequence Induction, Rapid Sequence Intubation, Rocuronium
- What is being tested?
- Train of four(TOF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to Dec 2022
- Phase
- Interventional
- 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 65 to 100 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Elective abdominal surgery
- Age > 65 years
- ASA I-II -III
Who cannot join
- Patient with history of allergy to rocuronium
- Body Mass Index > 35 kg/m2
- Patient who had history of difficult intubation or high possibility of difficult intubation
- Neuromuscular disease
- Kidney failure (GFR < 30 ml/dk/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Rocuronium Dosing Based on Ideal, Corrected or Total Body Weight on Rapid Sequence Intubation With Priming on Neuromuscular Blockage and Intubation Condition in Elderly Patients.
With the prolongation of life expectancy, the frequency of surgical intervention and anesthesia increases in elderly patients. The rapid Sequence Intubation(RSI) technique is preferred in patients with aspiration risk and who will undergo general anesthesia, especially in the pandemic period, to reduce or eliminate the aerosolization of respiratory secretions. The use of rocuronium at a dose of 1 mg/kg in RSI also causes prolongation of the recovery of neuromuscular block. This study aimed to compare the intubation conditions and train-of-four count(TOFC) 1-2 times of the rocuronium doses with priming according to ideal body weight(IBW), corrected body weight(CBW), and total body weight(TBW) in RSI of patients aged >65 years.
Read the detailed description
The number of elderly patients (>65 y) increases, and a large proportion of these patients will require surgery and anesthesia at some point. Changes in the neuromuscular junction, organ systems, and cardiac output that occur with aging cause changes in response to neuromuscular blockers. One of the reasons for rapid sequence intubation(RSI) preference is to reduce or eliminate aerosolization of respiratory secretions during general anesthesia and airway manipulation in surgical cases during the pandemic period. Guidelines regarding this subject recommend securing the airway quickly with RSI, and it is reported that aerosol production would decrease with this method. This study aimed to compare the intubation conditions and the train-of-four count (TOFC) 1 and 2 response times of the patients aged 65 and above, who were administered rocuronium at a priming dose (0.06 mg/kg) according to ideal body weight(IBW), corrected body weight(CBW), and total body weight (TBW) before induction, followed by administration of 0.94 mg/kg rocuronium 3 minutes after the anesthesia induction and intubated 45 seconds later.
- Being tested
- Train of four(TOF)
- Keywords
- Rapid Sequence Induction and Intubation, Rapid Sequence Intubation, Rocuronium, Geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train of four(TOF)Device
Train of four(TOF) monitoring after anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Ideal Body weight | Active comparator | ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR IDEAL BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION.
AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR IDEAL BODY WEIGHT WILL BE GIVEN. Receives: Device: Train of four(TOF) |
| Total Body Weight | Active comparator | ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR TOTAL BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION.
AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR TOTAL BODY WEIGHT WILL BE GIVEN. Receives: Device: Train of four(TOF) |
| Corrected Body Weight | Active comparator | ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR CORRECTED BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION.
AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR CORRECTED BODY WEIGHT WILL BE GIVEN. Receives: Device: Train of four(TOF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of excellent intubation condition
Score 1: Poor jaw relaxation/ Active resistance to blade/closing vokal kord/ Severe coughing or bucking/ Vigorous limb movement Score 2: Acceptable jaw relaxation/ Intermediate vokal cord moving/ slight limb and diaphram movement score 3: relaxed laryngoscopy/ abducted vocal cords/ no limb and diphragm movement
Measured: During intubation from start to finish of the study
TOF value during intubation procedure
Train of four monitoring during induction and intubation
Measured: During intubation from start to finish of the study
Time to TOFR equal to zero
Time from rocuronium induction to TOFR equal to zero
Measured: During intubation from start to finish of the study
Time to TOFC equal to 1
Time from rocuronium induction to TOFc equal to 1
Measured: During intubation from start to finish of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Jul 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence InductionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized contrrolled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysun postaci, Ankara City Hospital Bilkent
- Investigators
- Nadide Aysun Postacı, Principal investigator, aysunposta@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067829
- Sponsor's protocol ID
- E1-21-1849
- Status last verified
- May 2022
- First submitted
- 24 Sep 2021
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Rocuronium Dosing Based on Ideal, Corrected or Total Body Weight on Rapid Sequence Intubation With Priming on Neuromuscular Blockage and Intubation Condition in Elderly Patients.
- ClinicalTrials.gov ID
- NCT05067829
- Acronym / sponsor ID
- E1-21-1849
- Keywords
- Rapid Sequence Induction and Intubation, Rapid Sequence Intubation, Rocuronium, Geriatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Oct 2021 (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.
With the prolongation of life expectancy, the frequency of surgical intervention and anesthesia increases in elderly patients. The rapid Sequence Intubation(RSI) technique is preferred in patients with aspiration risk and who will undergo general anesthesia, especially in the pandemic period, to reduce or eliminate the aerosolization of respiratory secretions. The use of rocuronium at a dose of 1 mg/kg in RSI also causes prolongation of the recovery of neuromuscular block. This study aimed to compare the intubation conditions and train-of-four count(TOFC) 1-2 times of the rocuronium doses with priming according to ideal body weight(IBW), corrected body weight(CBW), and total body weight(TBW) in RSI of patients aged >65 years.
Detailed description
The number of elderly patients (>65 y) increases, and a large proportion of these patients will require surgery and anesthesia at some point. Changes in the neuromuscular junction, organ systems, and cardiac output that occur with aging cause changes in response to neuromuscular blockers. One of the reasons for rapid sequence intubation(RSI) preference is to reduce or eliminate aerosolization of respiratory secretions during general anesthesia and airway manipulation in surgical cases during the pandemic period. Guidelines regarding this subject recommend securing the airway quickly with RSI, and it is reported that aerosol production would decrease with this method. This study aimed to compare the intubation conditions and the train-of-four count (TOFC) 1 and 2 response times of the patients aged 65 and above, who were administered rocuronium at a priming dose (0.06 mg/kg) according to ideal body weight(IBW), corrected body weight(CBW), and total body weight (TBW) before induction, followed by administration of 0.94 mg/kg rocuronium 3 minutes after the anesthesia induction and intubated 45 seconds later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective randomized contrrolled study
| Arm | Type | Receives |
|---|---|---|
| Ideal Body weight | Active comparator | Device: Train of four(TOF)ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR IDEAL BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION. AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR IDEAL BODY WEIGHT WILL BE GIVEN. |
| Total Body Weight | Active comparator | Device: Train of four(TOF)ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR TOTAL BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION. AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR TOTAL BODY WEIGHT WILL BE GIVEN. |
| Corrected Body Weight | Active comparator | Device: Train of four(TOF)ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR CORRECTED BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION. AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR CORRECTED BODY WEIGHT WILL BE GIVEN. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elective abdominal surgery
- Age > 65 years
- ASA I-II -III
Key exclusion criteria (5 listed)
- Patient with history of allergy to rocuronium
- Body Mass Index > 35 kg/m2
- Patient who had history of difficult intubation or high possibility of difficult intubation
- Neuromuscular disease
- Kidney failure (GFR < 30 ml/dk/m2)
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 |
|---|---|---|
| Train of four(TOF)Train of four(TOF) monitoring after anesthesia induction | Device | Corrected Body Weight, Ideal Body weight, Total Body Weight |
Primary outcome
The percent of excellent intubation condition
Time frame: During intubation from start to finish of the study
Score 1: Poor jaw relaxation/ Active resistance to blade/closing vokal kord/ Severe coughing or bucking/ Vigorous limb movement Score 2: Acceptable jaw relaxation/ Intermediate vokal cord moving/ slight limb and diaphram movement score 3: relaxed laryngoscopy/ abducted vocal cords/ no limb and diphragm movement
TOF value during intubation procedure
Time frame: During intubation from start to finish of the study
Train of four monitoring during induction and intubation
Time to TOFR equal to zero
Time frame: During intubation from start to finish of the study
Time from rocuronium induction to TOFR equal to zero
Time to TOFC equal to 1
Time frame: During intubation from start to finish of the study
Time from rocuronium induction to TOFc equal to 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
Nadide Aysun Postacı principal investigator
aysunposta@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Train of four(TOF) in people with Rapid Sequence Induction and Rapid Sequence Intubation, run by Ankara City Hospital Bilkent 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadide Aysun Postacı (+905323520383, aysunposta@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of excellent intubation condition (time frame: During intubation from start to finish of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2022.