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Status unknownNCT02078583Updated Jul 16, 2014

The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients

A Phase 4 interventional study of Fentanyl and Remifentanil in Delirium, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Peking University People's Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.

02

Conditions studied

  • Delirium

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03

In context

Delirium

1,071 studies on the registry are indexed under Delirium; 239 are open to participants now.

This study's planned enrollment of 100 is below the median of 119 across 608 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signing a consent form
  • postoperative patient
  • Requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours
  • Requirement for sedation
  • Age more than 18 and less than 85 years old

Exclusion criteria

Exclusion Criteria:

  • Unstable blood circulation
  • Heart rate less than 50 beats per minute
  • II ° ~ III ° atrioventricular conduct block
  • Intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate;
  • Receipt of antipsychotics 、hypnotic drugs before surgery ;
  • Alcohol abuse;
  • Liver failure class Child-Pugh C;
  • Acute Respiratory Distress Syndrome;
  • Acute or chronic renal failure;
  • Other severe diseases ,septic shock;
  • Receipt of neuromuscular blocking drug;
  • Pregnancy and nursing woman;
  • Allergy to investigational drug or other contraindication.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Remifentanil,midazolam

    Remifentanil 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02\~0.1mg/kg/h continuous intravenous pump for 7days or extubation

    Drug: Remifentanil

  • Experimental
    Fentanyl,midazolam

    Fentanyl 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02\~0.1mg/kg/h continuous intravenous pump for 7days or extubation

    Drug: Fentanyl

  • Placebo comparator
    Normal saline

    Normal saline1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02\~0.1mg/kg/h continuous intravenous pump for 7days or extubation

    Drug: Normal saline

Interventions

06

What researchers measure

Primary outcomes

  1. The incidence and duration of delirium in patients with different regimens

    Time frame: 1 day

Secondary outcomes

  1. Mortality

    Time frame: 28 days

  2. Ventilator-free days

    Time frame: an expected average of 7 days

  3. Mean days of mechanical ventilation

    Time frame: an expected average of 7 days

  4. Length of ICU stay

    Time frame: an expected average of 7 days

  5. Index of anesthesia depth monitoring

    Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume

    Time frame: From admission to ICU to weaning,about 7 days

  6. Infusion velocity and total dose of sedative drugs in different groups

    Time frame: From admission to ICU to extubation or drug withdrawal,about 7 days

  7. Plasma melatonin level

    Time frame: Every 6 hours during the next ICU day

  8. Total rescue dose of midazolam

    Time frame: Seven days after giving midazolam to patient

  9. Variations of HR、RR、BP、SpO2

    Time frame: an expected average of 7 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02078583
Responsible party
Sponsor
First posted
Mar 5, 2014
Start date
Jul 2014
Primary completion
Jun 2015 (estimated)
Last update
Jul 16, 2014

Study contacts

Dan Liu, Resident physician
Contact
fancyjuice@126.com
+8613811365572
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Fentanyl · Remifentanil

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