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

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02078583
• Collaborator: (none)
• Enrollment: 100
• Arms: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Drug: Fentanyl; Drug: Remifentanil; Drug: Normal saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Study Start Date: Jul 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Mortality [28 days]

2. Ventilator-free days [an expected average of 7 days]

3. Mean days of mechanical ventilation [an expected average of 7 days]

4. Length of ICU stay [an expected average of 7 days]

5. Index of anesthesia depth monitoring [From admission to ICU to weaning,about 7 days]

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

6. Infusion velocity and total dose of sedative drugs in different groups [From admission to ICU to extubation or drug withdrawal,about 7 days]

7. Plasma melatonin level [Every 6 hours during the next ICU day]

8. Total rescue dose of midazolam [Seven days after giving midazolam to patient]

9. Variations of HR、RR、BP、SpO2 [an expected average of 7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT02078583
• Other Study ID Numbers: PEKING SEDATION
• First Posted: Mar 5, 2014
• Last Update Posted: Jul 16, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Delirium; Fentanyl; Remifentanil

Study Results

No Results Posted as of Jul 16, 2014