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

Delirium Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02078583
• Other study ID #: PEKING SEDATION
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 28, 2014
• Last updated: July 15, 2014
• Start date: July 2014

Study information

• Verified date: July 2014
• Source: Peking University People's Hospital
• Contact: Dan Liu, Resident physician
• Phone: +8613811365572
• Email: fancyjuice[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Fentanyl

• Remifentanil

• Normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and duration of delirium in patients with different regimens		1 day	No
Secondary	Mortality		28 days	No
Secondary	Ventilator-free days		an expected average of 7 days	No
Secondary	Mean days of mechanical ventilation		an expected average of 7 days	No
Secondary	Length of ICU stay		an expected average of 7 days	No
Secondary	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	From admission to ICU to weaning,about 7 days	No
Secondary	Infusion velocity and total dose of sedative drugs in different groups		From admission to ICU to extubation or drug withdrawal,about 7 days	No
Secondary	Plasma melatonin level		Every 6 hours during the next ICU day	No
Secondary	Total rescue dose of midazolam		Seven days after giving midazolam to patient	No
Secondary	Variations of HR?RR?BP?SpO2		an expected average of 7 days	No