- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02536690
Remifentanil and Midazolam on Propofol for Loss of Consciousness
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Gangnam-gu
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Seoul, Gangnam-gu, Korea, Republikken, 135-720
- Gangnam Severance Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- The patients who are scheduled to undergo general anesthesia for a surgery.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Group P
Induction with propofol bolus.
Dose will be started at 1 mg/kg and will be adjusted as described in summary.
|
Propofol bolusdoseadministrasjon i henhold til forhåndsbestemt dose ved biased coined design opp-og-ned-studie.
Andre navn:
|
Aktiv komparator: Group PR
Induction 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.
|
Propofol bolusdoseadministrasjon i henhold til forhåndsbestemt dose ved biased coined design opp-og-ned-studie.
Andre navn:
Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.
Andre navn:
|
Aktiv komparator: Group PMR
Induction 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. |
Propofol bolusdoseadministrasjon i henhold til forhåndsbestemt dose ved biased coined design opp-og-ned-studie.
Andre navn:
Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.
Andre navn:
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Loss of verbal response and eyelash reflex
Tidsramme: 2 minutes after propofol administration
|
Checking verbal response by verbal stimulation (yes or no) and reflex by palpation of the levator palpebrae (yes or no).
|
2 minutes after propofol administration
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean blood pressure
Tidsramme: 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
|
To compare differences among groups in mean blood pressure change (mmHg).
|
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
|
Heart rate
Tidsramme: 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
|
To compare differences among groups in heart rate change (mmHg).
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Dong Woo Han, MD, PhD, Department of Anesthesiology and Pain medicine, Gangnam Severance Hospital, Seoul, Korea
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Nevrologiske manifestasjoner
- Nevroatferdsmanifestasjoner
- Bevissthetsforstyrrelser
- Bevisstløshet
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anestesimidler, intravenøst
- Anestesimidler, general
- Bedøvelsesmidler
- Analgetika, opioid
- Narkotika
- Beroligende midler
- Psykotropiske stoffer
- Hypnotika og beroligende midler
- Adjuvanser, anestesi
- Anti-angst midler
- GABA modulatorer
- GABA-agenter
- Remifentanil
- Midazolam
- Propofol
Andre studie-ID-numre
- 2015-0183-004
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