AnesthesiaPhase 4NCT02709473
The Effect of Propofol and Remifentanil Sequence on ED50 and ED95 of Rocuronium in Rapid Sequence Induction Anesthesia
A Phase 4 study testing Propofol, Remifentanil and Rocuronium in people with Anesthesia and Neuromuscular Blockade, run by Ankara University at 2 sites in Turkey (Türkiye).
Trial summary
Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway in patients especially at risk of aspiration. Propofol and rocuronium are generally used agents for RSI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Neuromuscular Blockade
- What is being tested?
- Propofol, Remifentanil and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Mar 2016to Apr 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II patients
- patients scheduled for elective surgery
Who cannot join
- suspected or known difficult airway
- a significant renal or hepatic dysfunction
- a known neuromuscular disease
- hypertension
- a known allergy to one of the drugs used in general anesthesia
- a body mass index lower than 18.5 kg/m2 or higher than 30 kg/m2
- intake of any medication that might interact with rocuronium
- patient refusal
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara University
Ankara
Harran University
Sanliurfa
About this study
Official title: Does the Choice of Administration Sequence of Propofol and Remifentanil Affect the ED50 and ED95 of Rocuronium for Rapid Sequence Induction of Anesthesia?
Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway in patients especially at risk of aspiration. Propofol and rocuronium are generally used agents for RSI. However, the difficult airway scenarios are always valid for these patients, even without predictive signs of difficult airway. Therefore, it is important to decrease the rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with the aid of a reversal agent in case of difficult airway. The short acting opioids such as remifentanil may be helpful to reduce the dose of rocuronium in RSI.
Read the detailed description
Rapid sequence induction is a widely used anesthesia technique to achieve a safe airway control. However, the difficult airway may be expected in these patients as in the others. In the difficult airway situation, cholinesterase inhibitors and sugammadex may be used for the reversal. However, sugammadex is not always available due to its cost in every hospital. In addition to this, it is well-known that cholinesterase inhibitors do not work well in case of deep neuromuscular block. In consideration of these informations, the recovery of the neuromuscular block gain an importance in patients undergoing RSI with difficult airway. Therefore, decreasing the dosage of non-depolarizing neuromuscular agent may be helpful in case of the difficult airway situations. With the aim of decreasing the neuromuscular blocker dosage, opioid analgesics especially remifentanil is preferred combined with propofol to decrease the hemodynamic response to laryngoscopy and intubation. A recent study demonstrated that after induction of anesthesia with remifentanil and propofol, ED50 of rocuronium for acceptable intubation conditions was 0.20 mg/kg. In another study, the authors showed that the administration sequence of propofol and remifentanil for target controlled anesthesia affect the onset time of rocuronium due to change in cardiac output. The authors concluded that the prior administration of remifentanil decreased the cardiac output and delayed the onset time of rocuronium.
The investigators hypothesized that prior administration of remifentanil compared to propofol may increase the ED50 and ED95 of rocuronium for acceptable intubation conditions in RSI.
- Conditions
- Anesthesia, Neuromuscular Blockade
- Being tested
- Propofol, Remifentanil, Rocuronium
- Keywords
- propofol, remifentanil, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol will be used in either two arms. The injection sequence will be changed. In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds. And, then remifentanil will be given. In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection.
RemifentanilDrug
Also called Ultiva
Remifentanil will be used in either two arms. The injection sequence will be changed. In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds. And then propofol will be given. In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration.
RocuroniumDrug
Also called Esmeron
Rocuronium will be used for either two study arms. Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject. And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient. Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient. This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation).
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration Receives: Drug: Propofol; Drug: Remifentanil; Drug: Rocuronium |
| remifentanil | Active comparator | Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration Receives: Drug: Propofol; Drug: Remifentanil; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED50 of rocuronium
ED50 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 50% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED50 of rocuronium will be calculated as means of drug dosage that providing acceptable intubation condition.
Measured: One minute after rocuronium injection
ED95 of rocuronium
ED595 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 95% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED95 of rocuronium will be estimated by using statistical tools such as pava estimator or R code.
Measured: One minute after rocuronium injection
Secondary outcomes (1)
mean arterial blood pressure
the effect of propofol and remifentanil administration sequence on mean arterial blood pressure will be evaluated.
Measured: before and after 10 minutes of induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2016
- Study completionApr 2016
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menekse Ozcelik, Ankara University
- Investigators
- Ozlem Can, Assoc Prof, Study director, Ankara University Department of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709473
- Sponsor's protocol ID
- 31-31412
- Status last verified
- Jul 2016
- First submitted
- 23 Feb 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oh AY, Cho SJ, Seo KS, Ryu JH, Han SH, Hwang JW. Dose of rocuronium for rapid tracheal intubation following remifentanil 2 mug kg-1 and propofol 2 mg kg-1. Eur J Anaesthesiol. 2013 Sep;30(9):550-5. doi: 10.1097/EJA.0b013e3283622ba0.
PubMed 23698704Na HS, Hwang JW, Park SH, Oh AY, Park HP, Jeon YT, Do SH. Drug-administration sequence of target-controlled propofol and remifentanil influences the onset of rocuronium. A double-blind, randomized trial. Acta Anaesthesiol Scand. 2012 May;56(5):558-64. doi: 10.1111/j.1399-6576.2012.02648.x. Epub 2012 Feb 7.
PubMed 22313514Dewhirst E, Tobias JD, Martin DP. Propofol and remifentanil for rapid sequence intubation in a pediatric patient at risk for aspiration with elevated intracranial pressure. Pediatr Emerg Care. 2013 Nov;29(11):1201-3. doi: 10.1097/PEC.0b013e3182aa136d.
PubMed 24196089
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Choice of Administration Sequence of Propofol and Remifentanil Affect the ED50 and ED95 of Rocuronium for Rapid Sequence Induction of Anesthesia?
- ClinicalTrials.gov ID
- NCT02709473
- Acronym / sponsor ID
- 31-31412
- Conditions
- Anesthesia, Neuromuscular Blockade
- Keywords
- propofol, remifentanil, rocuronium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Mar 2016 (estimated)
- 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.
Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway in patients especially at risk of aspiration. Propofol and rocuronium are generally used agents for RSI. However, the difficult airway scenarios are always valid for these patients, even without predictive signs of difficult airway. Therefore, it is important to decrease the rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with the aid of a reversal agent in case of difficult airway. The short acting opioids such as remifentanil may be helpful to reduce the dose of rocuronium in RSI.
Detailed description
Rapid sequence induction is a widely used anesthesia technique to achieve a safe airway control. However, the difficult airway may be expected in these patients as in the others. In the difficult airway situation, cholinesterase inhibitors and sugammadex may be used for the reversal. However, sugammadex is not always available due to its cost in every hospital. In addition to this, it is well-known that cholinesterase inhibitors do not work well in case of deep neuromuscular block. In consideration of these informations, the recovery of the neuromuscular block gain an importance in patients undergoing RSI with difficult airway. Therefore, decreasing the dosage of non-depolarizing neuromuscular agent may be helpful in case of the difficult airway situations. With the aim of decreasing the neuromuscular blocker dosage, opioid analgesics especially remifentanil is preferred combined with propofol to decrease the hemodynamic response to laryngoscopy and intubation. A recent study demonstrated that after induction of anesthesia with remifentanil and propofol, ED50 of rocuronium for acceptable intubation conditions was 0.20 mg/kg. In another study, the authors showed that the administration sequence of propofol and remifentanil for target controlled anesthesia affect the onset time of rocuronium due to change in cardiac output. The authors concluded that the prior administration of remifentanil decreased the cardiac output and delayed the onset time of rocuronium.
The investigators hypothesized that prior administration of remifentanil compared to propofol may increase the ED50 and ED95 of rocuronium for acceptable intubation conditions in RSI.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: Propofol, Drug: Remifentanil, Drug: RocuroniumPropofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration |
| remifentanil | Active comparator | Drug: Propofol, Drug: Remifentanil, Drug: RocuroniumRemifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-II patients
- patients scheduled for elective surgery
Key exclusion criteria (8 listed)
- suspected or known difficult airway
- a significant renal or hepatic dysfunction
- a known neuromuscular disease
- hypertension
- a known allergy to one of the drugs used in general anesthesia
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 |
|---|---|---|
| PropofolPropofol will be used in either two arms. The injection sequence will be changed. In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds. And, then remifentanil will be given. In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection. | Drug | propofol, remifentanil |
| RemifentanilAlso: UltivaRemifentanil will be used in either two arms. The injection sequence will be changed. In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds. And then propofol will be given. In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration. | Drug | propofol, remifentanil |
| RocuroniumAlso: EsmeronRocuronium will be used for either two study arms. Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject. And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient. Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient. This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation). | Drug | propofol, remifentanil |
Primary outcome
ED50 of rocuronium
Time frame: One minute after rocuronium injection
ED50 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 50% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED50 of rocuronium will be calculated as means of drug dosage that providing acceptable intubation condition.
ED95 of rocuronium
Time frame: One minute after rocuronium injection
ED595 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 95% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED95 of rocuronium will be estimated by using statistical tools such as pava estimator or R code.
1 secondary outcome
mean arterial blood pressure
Time frame: before and after 10 minutes of induction of anesthesia
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 12 Jul 2016.
- Background: PubMed 23698704Oh AY, Cho SJ, Seo KS, Ryu JH, Han SH, Hwang JW. Dose of rocuronium for rapid tracheal intubation following remifentanil 2 mug kg-1 and propofol 2 mg kg-1. Eur J Anaesthesiol. 2013 Sep;30(9):550-5. doi: 10.1097/EJA.0b013e3283622ba0.
- Background: PubMed 22313514Na HS, Hwang JW, Park SH, Oh AY, Park HP, Jeon YT, Do SH. Drug-administration sequence of target-controlled propofol and remifentanil influences the onset of rocuronium. A double-blind, randomized trial. Acta Anaesthesiol Scand. 2012 May;56(5):558-64. doi: 10.1111/j.1399-6576.2012.02648.x. Epub 2012 Feb 7.
- Background: PubMed 24196089Dewhirst E, Tobias JD, Martin DP. Propofol and remifentanil for rapid sequence intubation in a pediatric patient at risk for aspiration with elevated intracranial pressure. Pediatr Emerg Care. 2013 Nov;29(11):1201-3. doi: 10.1097/PEC.0b013e3182aa136d.
- 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.
Ozlem Can, Assoc Prof study director
Ankara University Department of Anesthesiology and Intensive Care Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Remifentanil and Rocuronium in people with Anesthesia and Neuromuscular Blockade, run by Ankara University at 2 sites 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 2 inclusion and 8 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ED50 of rocuronium (time frame: One minute after rocuronium injection). The study lists 2 primary outcomes in all. 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 NCT02709473, 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 12 Jul 2016.