Urologic SurgeryPhase 4PreopDXMNCT02097407
Preoperative Dexmedetomidine & EC50 of Propofol
A Phase 4 study testing Group C : Saline + propofol group and Group D : Dexmedetomidine + propofol group in people with Urologic Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective randomised study, we determined whether preoperative dexmedetomidine administration could reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM insertion without muscle relaxants. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Urologic Surgery
- What is being tested?
- Group C : Saline + propofol group and Group D : Dexmedetomidine + propofol group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Aug 2012
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery
Who cannot join
- Patients with an allergy to alpha-2 adrenergic agonists or propofol
- Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of <2.5 cm, and/or body mass index of >30 kg m-2), unstable teeth
- Patients with bradycardia of <50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
- Patients with symptoms of upper respiratory infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Dexmedetomidine Reduces the EC50 of Propofol for Successful i-gelTM Insertion Without Muscle Relaxants
Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective randomised study, we determined whether preoperative dexmedetomidine administration could reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM insertion without muscle relaxants.
Read the detailed description
Propofol is a useful induction agent for LMA insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. A previous report showed that the effect-site concentration of propofol for successful classic LMA insertion in 50% of adults (EC50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. The EC50 of propofol may be dependent on the type of LMA used. A previous study comparing the EC50 of the propofol concentration between classic and proseal LMA insertions demonstrated that the EC50 of propofol needed for proseal LMA insertion was 35% greater than that needed for classic LMA insertion. Unfortunately, no investigation has been performed to determine the EC50 of the propofol concentration required for i-gel insertion without muscle relaxants.
Dexmedetomidine (DEX), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. Such beneficial characteristics make DEX a useful anaesthetic adjuvant for general anaesthesia. Many reports have revealed the beneficial effects of DEX in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. A previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the EC50 required for LMA insertion.
We hypothesised that preoperative DEX administration can reduce the propofol concentration required for i-gel insertion. In this study, we compared the EC50 of propofol needed for successful i-gel insertion without muscle relaxants between DEX and placebo groups
- Conditions
- Urologic Surgery
- Being tested
- Group C : Saline + propofol group, Group D : Dexmedetomidine + propofol group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group C : Saline + propofol groupDrug
All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min.
After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment
Group D : Dexmedetomidine + propofol groupDrug
All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min.
After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Group D : Dexmedetomidine + propofol group | Experimental | In Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia. Receives: Drug: Group D : Dexmedetomidine + propofol group |
| Group C : Saline + propofol group | Placebo comparator | In Group C, 0.9% of normal saline (1 µg kg-1) was loaded 10 min before induction of anaeshtesia. Receives: Drug: Group C : Saline + propofol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
EC50 of propofol required for successful i-gel insertion
The EC50 of propofol for successful i-gel insertion was determined by a modification of Dixon's up-and-down method. The response of each patient determined the effect-site propofol concentration for the next patient. If the response was deemed 'successful', the next target concentration of propofol was decreased by 0.5 µg mL-1. If the response was deemed a 'failure', the target concentration was increased by the same dose. The process was repeated until the sixth crossover point (success/failure) was obtained.
Measured: During i-gel insertion anticipated up to 1 min
Secondary outcomes (2)
the total dose of propofol infused before i-gel insertion
The total amount of propofol infused before i-gel insertion was noted. The insertion time, defined as the time from picking up the i-gel until the initiation of mechanical ventilation.
Measured: During i-gel insertion time anticipated upto 1min
the presence/severity of airway trauma after i-gel insertion
After removing the i-gel, airway trauma (defined as any blood staining on the device) was recorded.
Measured: At the time point of removing the i-gel from patient's mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urologic SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee Pyung Park, MD PhD, Study director, ProfessorYoung Cheol Kim, Md PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097407
- Sponsor's protocol ID
- PreopDXM_PPF
- Acronym
- PreopDXM
- Status last verified
- Mar 2014
- First submitted
- 24 Mar 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jang YE, Kim YC, Yoon HK, Jeon YT, Hwang JW, Kim E, Park HP. A randomized controlled trial of the effect of preoperative dexmedetomidine on the half maximal effective concentration of propofol for successful i-gel insertion without muscle relaxants. J Anesth. 2015 Jun;29(3):338-345. doi: 10.1007/s00540-014-1949-9. Epub 2014 Nov 14.
PubMed 25394762
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Dexmedetomidine Reduces the EC50 of Propofol for Successful i-gelTM Insertion Without Muscle Relaxants
- ClinicalTrials.gov ID
- NCT02097407
- Acronym / sponsor ID
- PreopDXM / PreopDXM_PPF
- Conditions
- Urologic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Mar 2014 (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.
Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective randomised study, we determined whether preoperative dexmedetomidine administration could reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM insertion without muscle relaxants.
Detailed description
Propofol is a useful induction agent for LMA insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. A previous report showed that the effect-site concentration of propofol for successful classic LMA insertion in 50% of adults (EC50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. The EC50 of propofol may be dependent on the type of LMA used. A previous study comparing the EC50 of the propofol concentration between classic and proseal LMA insertions demonstrated that the EC50 of propofol needed for proseal LMA insertion was 35% greater than that needed for classic LMA insertion. Unfortunately, no investigation has been performed to determine the EC50 of the propofol concentration required for i-gel insertion without muscle relaxants.
Dexmedetomidine (DEX), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. Such beneficial characteristics make DEX a useful anaesthetic adjuvant for general anaesthesia. Many reports have revealed the beneficial effects of DEX in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. A previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the EC50 required for LMA insertion.
We hypothesised that preoperative DEX administration can reduce the propofol concentration required for i-gel insertion. In this study, we compared the EC50 of propofol needed for successful i-gel insertion without muscle relaxants between DEX and placebo groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D : Dexmedetomidine + propofol group | Experimental | Drug: Group D : Dexmedetomidine + propofol groupIn Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia. |
| Group C : Saline + propofol group | Placebo comparator | Drug: Group C : Saline + propofol groupIn Group C, 0.9% of normal saline (1 µg kg-1) was loaded 10 min before induction of anaeshtesia. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery
Key exclusion criteria (4 listed)
- Patients with an allergy to alpha-2 adrenergic agonists or propofol
- Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of <2.5 cm, and/or body mass index of >30 kg m-2), unstable teeth
- Patients with bradycardia of <50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
- Patients with symptoms of upper respiratory infection
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 |
|---|---|---|
| Group C : Saline + propofol groupAll patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment | Drug | Group C : Saline + propofol group |
| Group D : Dexmedetomidine + propofol groupAll patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment. | Drug | Group D : Dexmedetomidine + propofol group |
Primary outcome
EC50 of propofol required for successful i-gel insertion
Time frame: During i-gel insertion anticipated up to 1 min
The EC50 of propofol for successful i-gel insertion was determined by a modification of Dixon's up-and-down method. The response of each patient determined the effect-site propofol concentration for the next patient. If the response was deemed 'successful', the next target concentration of propofol was decreased by 0.5 µg mL-1. If the response was deemed a 'failure', the target concentration was increased by the same dose. The process was repeated until the sixth crossover point (success/failure) was obtained.
2 secondary outcomes
the total dose of propofol infused before i-gel insertion
Time frame: During i-gel insertion time anticipated upto 1min
the presence/severity of airway trauma after i-gel insertion
Time frame: At the time point of removing the i-gel from patient's mouth
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 27 Mar 2014.
- Derived from this study: PubMed 25394762Jang YE, Kim YC, Yoon HK, Jeon YT, Hwang JW, Kim E, Park HP. A randomized controlled trial of the effect of preoperative dexmedetomidine on the half maximal effective concentration of propofol for successful i-gel insertion without muscle relaxants. J Anesth. 2015 Jun;29(3):338-345. doi: 10.1007/s00540-014-1949-9. Epub 2014 Nov 14.
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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.
Hee Pyung Park, MD PhD study director
Professor
Young Cheol Kim, Md PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group C : Saline + propofol group and Group D : Dexmedetomidine + propofol group in people with Urologic Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 27 Mar 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
EC50 of propofol required for successful i-gel insertion (time frame: During i-gel insertion anticipated up to 1 min). 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 NCT02097407, which also lists 1 linked publication.
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 27 Mar 2014.