- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04284644
Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques
A Novel Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques: a Prospective Randomized Control Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. This technique is considered an approach that can be of a great benefit to patients with chronic medical illnesses and those who have moderate to high risk for general anaesthesia.
In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction. The investigators evaluated the time needed for laryngeal mask airway (LMA) insertion, number of LMA insertion trials, succession of LMA insertion, adverse events related to the airway, respiratory and cardiovascular systems, haemodynamic stability and satisfaction scores of enrolled patients.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Amman, Jordanien, 11942
- Jordan University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- patients with Age ≥ 65 years.
- American Society of Anaesthesiologists' (ASA) score II or III.
- minimally invasive endoscopic urological procedures.
Exclusion Criteria:
- patient refusal.
- Age < 65 years.
- family history of malignant hyperthermia.
- prolonged surgery that needed intubation.
- body mass index (BMI) > 35 kg/m2.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Group P
Patient received a dose of 1.5 mg/kg of Propofol slowly over 2 minutes for induction.
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Patients were given 1.5 mcg/Kg of fentanyl intravenously.
two minutes after the fentanyl dose, a dose of 1.5 mg/kg of propofol slowly over 2 minutes.
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Experimentell: Group S
Patient received 8% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen.
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Patients were given 1.5 mcg/Kg of fentanyl intravenously.
two minutes after the fentanyl dose, patient received 8% inhalational sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen.
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Experimentell: Group C
Patient received 4% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly.
|
Patients were given 1.5 mcg/Kg of fentanyl intravenously.
two minutes after the fentanyl dose, patient received 4% sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Intraoperative respiratory adverse events
Tidsram: 8 months
|
The investigators recorded the occurrence of transient apnea intraoperatively, in addition to laryngeal spasm, coughing, gagging and increased salivation.
The study chart included the documentation these common adverse events, the timing of occurrence, and the intervention required to manage these events.
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8 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time for successful laryngeal mask airway insertion
Tidsram: 8 months
|
The investigators assessed the time needed for LMA insertion.
The timer was started upon giving the fentanyl, recording the time till successful insertion of laryngeal mask airway.
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8 months
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Blood pressure stability
Tidsram: 8 months
|
The investigators recorded patients' blood pressure readings throughout the induction procedure.
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8 months
|
Heart rate stability
Tidsram: 8 months
|
The investigators recorded patients' heart rate throughout the induction procedure.
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8 months
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Changes in oxygen saturation
Tidsram: 8 months
|
The investigators recorded patients' oxygen saturation throughout the induction procedure.
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8 months
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10/2016/4597
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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