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AnesthesiaNCT02536690

Remifentanil and Midazolam on Propofol for Loss of Consciousness

A study testing Propofol, Remifentanil and Midazolam in people with Anesthesia, run by Severance Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect. The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). Read more about this study

Who is it for?
Ages 20 to 50 years, women only
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
Aug 2015to May 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 20 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • The patients who are scheduled to undergo general anesthesia for a surgery.

Who cannot join

  • ASA class (American Society of Anesthesiologist physical status classification) II 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
  • Pregnancy
  • Patients taking sedatives or hypnotic agents.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Gangnam Severance hospital

    Seoul, Gangnam-gu, 135-720

Other trials in South Korea

About this study

Official title: The Effect of Remifentanil and Midazolam on Propofol for Loss of Consciousness During Induction of Anesthesia

Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect.

The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.25 mcg/kg/min remifentanil infusion prior to propofol. The patients in group PMR will receive 0.03 mg/kg bolus dose of midazolam 1 min after start of the remifentanil infusion. 'Success' is defined as loss of both verbal response and eyelash reflex in 2 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.25 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. 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 patients 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 0.25 mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in group PMR will receive 0.03 mg/kg bolus dose of midazolam 1 min after the start of the remifentanil infusion. Initial propofol dose will be 1 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 2 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.25 mg/kg higher dose of propofol at induction period.

Conditions
Anesthesia
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 0.25 mcg/kg/min infusion for 5 min before propofol administration.

  • MidazolamDrug

    Also called Vascam

    Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.03 mg/kg administration 1 min after remifentanil infusion start.

Study groups in NCT02536690
Study groupRoleWhat they receive
Group PActive comparatorInduction with propofol bolus. Dose will be started at 1 mg/kg and will be adjusted as described in summary.
Receives: Drug: Propofol
Group PRActive comparatorInduction with propofol and remifentanil. Remifentanil infusion 0.25 mcg/kg/min for 5 min followed by propofol bolus Propofol dose will be started at 1 mg/kg and will be adjusted as described in summary.
Receives: Drug: Propofol; Drug: Remifentanil
Group PMRActive comparatorInduction with propofol, midazolam and remifentanil. Remifentanil infusion 0.25 mcg/kg/min for 5 min followed by midazolam 0.03 mg/kg bolus 1 min after remifentanil infusion start and propofol bolus administration. Propofol dose will be started at 1 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.

  1. Loss of verbal response and eyelash reflex

    Checking verbal response by verbal stimulation (yes or no) and reflex by palpation of the levator palpebrae (yes or no).

    Measured: 2 minutes after propofol administration

Secondary outcomes (2)

  1. 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 and 2 minutes after propofol administration

  2. 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 and 2 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.

  1. First posted1 Sep 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02536690
Sponsor's protocol ID
2015-0183-004
Status last verified
May 2016
First submitted
24 Aug 2015
Last updated
2 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

  • Choi SH, Min KT, Lee JR, Choi KW, Han KH, Kim EH, Oh HJ, Lee JH. Determination of EC95 of remifentanil for smooth emergence from propofol anesthesia in patients undergoing transsphenoidal surgery. J Neurosurg Anesthesiol. 2015 Apr;27(2):160-6. doi: 10.1097/ANA.0000000000000094.

    PubMed 25105828

  • Koh JC, Park J, Kim NY, You AH, Ko SH, Han DW. Effects of remifentanil with or without midazolam pretreatment on the 95% effective dose of propofol for loss of consciousness during induction: A randomized, clinical trial. Medicine (Baltimore). 2017 Dec;96(49):e9164. doi: 10.1097/MD.0000000000009164.

    PubMed 29245361

Questions about this trial

What is this clinical trial studying?

A study testing Propofol, Remifentanil and Midazolam in people with Anesthesia, run by 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 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: finished, as of the sponsor's last update on 2 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?

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?

Loss of verbal response and eyelash reflex (time frame: 2 minutes after propofol administration). 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 NCT02536690, 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 2 Jun 2016.

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