AnesthesiaNCT02818387
Remifentanil and Midazolam on Propofol for Loss of Consciousness in Elderly Patients
A study testing Propofol, Remifentanil and Midazolam in people with Anesthesia, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Propofol is a well-known induction agent which can provide sound and quick hypnosis with anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while using this agent. Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol, Remifentanil and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia.
Who cannot join
- ASA class (American Society of Anesthesiologist physical status classification) IV or higher
- Patients with history of allergy or side effects on propofol, remifentanil, midazolam
- BMI (body mass index) less than 20 or higher than 30
- Patients taking sedatives or hypnotic agents.
Trial locations and contacts
1 site in 1 country.
Jiwon An, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, 135-720
Dong Woo Han, MD, PhD, 82-2-2019-3520
About this study
Official title: The Effect of Remifentanil and Midazolam on Propofol for Loss of Consciousness During Induction of Anesthesia in Elderly Patients
Propofol is a well-known induction agent which can provide sound and quick hypnosis with anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while using this agent. Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect in elderly patients. There are not many studies which provide minimum dose of propofol to induce hypnosis in combination with these agents and advantage of the combination.
The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). Sample size have been decided due to the previous studies which have mentioned 40 participants as a adequate sample size for this biased coin design - up and down study.
Read more
After receiving informed consent, patients will be participated in this study. No premedication will be given to the patients before induction. The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.125 mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose will be changed by the result of prior study participant.
'Success' of this study will be defined as loss of both verbal response and eyelash reflex in 3 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at induction period.
Read the detailed description
Propofol is a well-known induction agent which can provide sound and quick hypnosis with anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while using this agent. Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect in elderly patients. There are not many studies which provide minimum dose of propofol to induce hypnosis in combination with these agents and advantage of the combination.
The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). Sample size have been decided due to the previous studies which have mentioned 40 participants as a adequate sample size for this biased coin design - up and down study.
After receiving informed consent, patients will be participated in this study. No premedication will be given to the patients before induction. The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.125 mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose will be changed by the result of prior study participant.
'Success' of this study will be defined as loss of both verbal response and eyelash reflex in 3 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at induction period.
- Conditions
- Anesthesia
- Being tested
- Propofol, Remifentanil, Midazolam
- Keywords
- propofol, midazolam, remifentanil, combination, synergic, pharmacodynamics, Loss of consciousness
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Fresofol
Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.
RemifentanilDrug
Also called Ultiva
Remifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration.
MidazolamDrug
Remifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.015 mg/kg administration 1 min after remifentanil infusion start.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Induction with propofol bolus. Dose will be started at 0.5 mg/kg and will be adjusted as described in summary. Receives: Drug: Propofol |
| Group PR | Active comparator | Induction with propofol and remifentanil. Remifentanil infusion 0.125 mcg/kg/min for 5 min followed by propofol bolus Propofol dose will be started at 0.5 mg/kg and will be adjusted as described in summary. Receives: Drug: Propofol; Drug: Remifentanil |
| Group PMR | Active comparator | Induction with propofol, midazolam and remifentanil. Remifentanil infusion 0.125 mcg/kg/min for 5 min followed by midazolam 0.015 mg/kg bolus 1 min after remifentanil infusion start and propofol bolus administration.
Propofol dose will be started at 0.5 mg/kg and will be adjusted as described in summary. Receives: Drug: Propofol; Drug: Remifentanil; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of verbal response and eyelash reflex
Checking verbal response by verbal stimulation (response or no response).
Measured: 3 minutes after propofol administration
Loss of eyelash reflex
Checking reflex by palpation of the levator palpebrae (reflex or no reflex).
Measured: 3 minutes after propofol administration
Secondary outcomes (2)
Mean blood pressure
To compare differences among groups in mean blood pressure change (mmHg)
Measured: baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute, 2 minutes and 3 minutes after propofol administration
Heart rate
To compare differences among groups in heart rate change (mmHg)
Measured: baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute, 2 minutes and 3 minutes after propofol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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 AnesthesiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwon An, Gangnam Severance Hospital
- Investigators
- Dong Woo Han, MD,PhD, Study chair, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818387
- Sponsor's protocol ID
- 3-2015-0222
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Conway DH, Hasan SK, Simpson ME. Target-controlled propofol requirements at induction of anaesthesia: effect of remifentanil and midazolam. Eur J Anaesthesiol. 2002 Aug;19(8):580-4. doi: 10.1017/s0265021502000935.
PubMed 12200947
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remifentanil and Midazolam on Propofol for Loss of Consciousness During Induction of Anesthesia in Elderly Patients
- ClinicalTrials.gov ID
- NCT02818387
- Acronym / sponsor ID
- 3-2015-0222
- Conditions
- Anesthesia
- Keywords
- propofol, midazolam, remifentanil, combination, synergic, pharmacodynamics, Loss of consciousness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 29 Jun 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.
Propofol is a well-known induction agent which can provide sound and quick hypnosis with anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while using this agent. Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect in elderly patients. There are not many studies which provide minimum dose of propofol to induce hypnosis in combination with these agents and advantage of the combination.
The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). Sample size have been decided due to the previous studies which have mentioned 40 participants as a adequate sample size for this biased coin design - up and down study.
After receiving informed consent, patients will be participated in this study. No premedication will be given to the patients before induction. The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.125 mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose will be changed by the result of prior study participant.
'Success' of this study will be defined as loss of both verbal response and eyelash reflex in 3 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at induction period.
Detailed description
Propofol is a well-known induction agent which can provide sound and quick hypnosis with anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while using this agent. Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect in elderly patients. There are not many studies which provide minimum dose of propofol to induce hypnosis in combination with these agents and advantage of the combination.
The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). Sample size have been decided due to the previous studies which have mentioned 40 participants as a adequate sample size for this biased coin design - up and down study.
After receiving informed consent, patients will be participated in this study. No premedication will be given to the patients before induction. The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.125 mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose will be changed by the result of prior study participant.
'Success' of this study will be defined as loss of both verbal response and eyelash reflex in 3 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at induction period.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: PropofolInduction with propofol bolus. Dose will be started at 0.5 mg/kg and will be adjusted as described in summary. |
| Group PR | Active comparator | Drug: Propofol, Drug: RemifentanilInduction with propofol and remifentanil. Remifentanil infusion 0.125 mcg/kg/min for 5 min followed by propofol bolus Propofol dose will be started at 0.5 mg/kg and will be adjusted as described in summary. |
| Group PMR | Active comparator | Drug: Propofol, Drug: Remifentanil, Drug: MidazolamInduction with propofol, midazolam and remifentanil. Remifentanil infusion 0.125 mcg/kg/min for 5 min followed by midazolam 0.015 mg/kg bolus 1 min after remifentanil infusion start and propofol bolus administration. Propofol dose will be started at 0.5 mg/kg and will be adjusted as described in summary. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia.
Key exclusion criteria (4 listed)
- ASA class (American Society of Anesthesiologist physical status classification) IV or higher
- Patients with history of allergy or side effects on propofol, remifentanil, midazolam
- BMI (body mass index) less than 20 or higher than 30
- Patients taking sedatives or hypnotic agents.
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 |
|---|---|---|
| PropofolAlso: FresofolPropofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study. | Drug | Group P, Group PMR, Group PR |
| RemifentanilAlso: UltivaRemifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration. | Drug | Group PMR, Group PR |
| MidazolamRemifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.015 mg/kg administration 1 min after remifentanil infusion start. | Drug | Group PMR |
Primary outcome
Loss of verbal response and eyelash reflex
Time frame: 3 minutes after propofol administration
Checking verbal response by verbal stimulation (response or no response).
Loss of eyelash reflex
Time frame: 3 minutes after propofol administration
Checking reflex by palpation of the levator palpebrae (reflex or no reflex).
2 secondary outcomes
Mean blood pressure
Time frame: baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute, 2 minutes and 3 minutes after propofol administration
Heart rate
Time frame: baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute, 2 minutes and 3 minutes after propofol administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Background: PubMed 12200947Conway DH, Hasan SK, Simpson ME. Target-controlled propofol requirements at induction of anaesthesia: effect of remifentanil and midazolam. Eur J Anaesthesiol. 2002 Aug;19(8):580-4. doi: 10.1017/s0265021502000935.
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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.
Jiwon An, MD contact
Dong Woo Han, MD,PhD study chair
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol, Remifentanil and Midazolam in people with Anesthesia, run by Gangnam Severance 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: status not confirmed, as of the sponsor's last update on 29 Jun 2016. 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. 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 Jiwon An, MD (82-2-2019-3520), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of verbal response and eyelash reflex (time frame: 3 minutes after propofol administration). 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 NCT02818387, 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 29 Jun 2016.