Post-Marketing Clinical Study to Assess Efficacy and Safety of Dexmedetomidine in Post-Operative Patients

Conscious Sedation Clinical Trial

Official title:

A Post-Marketing, Open-Label, Randomized, Comparative Study Comparing the Usefulness of Dexmedetomidine at the Time of Extubation and Post Extubation Period to Other Sedative Management in Post-Operative Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318955
• Other study ID #: DEX-401
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2006
• Last updated: March 16, 2017
• Start date: November 2005
• Est. completion date: August 2006

Study information

• Verified date: June 2015
• Source: Hospira, now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy and safety of dexmedetomidine at the time of extubation and after extubation, in patients requiring postoperative sedation in the ICU.

Description:

The study is to conduct as a phase IV post-marketing clinical study in accordance with the approval condition of dexmedetomidine hydrochloride in Japan. The study will compare the use of dexmedetomidine in patient management at the time of extubation with other sedative/ analgesic management, Comparison is made in the use of dexmedetomidine in patient management between a group in which management is performed with dexmedetomidine and a group in which standard management is performed with propofol in patients requiring postoperative sedation in the ICU The usefulness of dexmedetomidine during postextubation period is also evaluated.

Other known NCT identifiers

• NCT00248001

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patient or legally acceptable representative (if acceptable by Institutional Review Board/Ethics Committee) has signed and dated the Informed Consent after the study has been fully explained.

• Patient is male or female; at least 20 years of age.

• Patient who is in condition of American Society of Anesthesiology (ASA) I to III Class preoperatively

• Patient is orally intubated and anticipated to require sedation for mechanical ventilation for a minimum period of 4 hours following open-heart surgery, coronary artery bypass grafting (CABG), or major vascular surgery

• If patient is female with child bearing potential, she is to be non-pregnant, and not lactating

Exclusion Criteria:

• Patient with serious disturbance of the central nervous system (disturbance of consciousness).

• Patient has undergone or requires intracranial surgery during current hospitalization

• Patient requires muscle relaxant drugs after admission to the ICU (except when an endotracheal tube is reinserted).

• Patient requires epidural or intrathecal administration of analgesia/anesthesia after surgery and during their ICU stay.

• Patients for whom propofol or opioids are contraindicated.

• Patient has known or suspected allergies to any medication that might be administered during the course of the study.

• Patient is obese (body mass index >35)

• Patient was recently hospitalized for drug overdose

• Patient for whom alpha-2 antagonists or alpha-2 agonists are contraindicated

• Patient is currently or previously treated, within 30 days before the start of the study, with an alpha-2 antagonist or alpha-2 receptor agonist.

• Patient has participated in another clinical study within 30 days prior to admission to the ICU and patient is currently participating in another clinical study.

• Patient was diagnosed with severe symptoms and judged likely to die within 24 hours.

• Patient is considered unable to undergo all procedures required by the protocol.

• Patient with excessive bleeding that is likely require reoperation.

• Patient with an ejection fraction of < 30%.

• Patient, in the opinion of the investigator or subinvestigator in the post-marketing clinical study, that has symptoms or factors that may increase his/her risk as a result of the clinical study, or that may not provide sufficient study data.

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Dexmedetomidine

• Propofol

Locations

Country	Name	City	State
Japan	Nippon Medical School Hospital	Bunkyo-ku	Tokyo
Japan	Hamamatsu University Hospital	Hamamatsu-City	Shizuoka
Japan	Kyushu University Hospital	Higashi-ku	Fukuoka
Japan	Hirosaki University Hospital	Hirosaki-shi	Aomori
Japan	Kagoshima University Medical and Dental Hospital	Kagoshima
Japan	Osaka City General Hospital	Miyakojima-ku	Osaka
Japan	Nagasaki University Hospital of Medicine and Dentistry	Nagasaki
Japan	Okayama University Hospital of Medicine and Dentistry	Okayama
Japan	Kinki University Hospital	Osaka-Sayama-Shi	Osaka
Japan	Kyoto University Hospital	Sakyoku	Kyoto
Japan	Showa University Hospital	Shinagawa-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Hospira, now a wholly owned subsidiary of Pfizer	Maruishi Pharmaceutical

Country where clinical trial is conducted

Japan, 

References & Publications (12)

Aitkenhead AR. Analgesia and sedation in intensive care. Br J Anaesth. 1989 Aug;63(2):196-206. Review. — View Citation

Costas Katsanoulas. Concluding Remarks: Redefining Intensive Care Unit Sedation, International Congress and Symposium Series 221, 83-88

Greenblatt DJ, Divoll M, Abernethy DR, Ochs HR, Shader RI. Clinical pharmacokinetics of the newer benzodiazepines. Clin Pharmacokinet. 1983 May-Jun;8(3):233-52. Review. — View Citation

Hewitt PB. Subjective follow-up of patients from a surgical intensive therapy ward. Br Med J. 1970 Dec 12;4(5736):669-73. — View Citation

Hidekazu Yukioka, et.al. Current status of analgesic and sedation control in ICU. Japan ICU Treatment Association's Magazine 1:13-19, 1994

Ikuto Yoshiya. Section 4; Pharmacology for Anesthesia, Introduction to Anesthesiology, 7th edition, Nagai Shoten,pp439-447, 1993

Ikuto Yoshiya: Sedation and Analgesia for Intensive Care Patients. Anesthesia 21(2):2-6, 333-337, 2000

Mantz,J., Singer,M. Importance of Patient Orientation and Rousability as Components of Intensive Care Unit Sedation, International Congress and Symposium Series 221, 23-29

Masayoshi Hyodo et.al. Anesthetic Science, 10th edition, Kinpodo, ppl 213-219

Megumu Tagami et.al. Post-operative analgesic and sedation control,

Minoru Kaneshiro. Analgesic and Sedatin during mechanical ventilation, ICU and CCU 14:14643-648,1990

Syu Matsukawa, et.al.Sedation during ventilation control, ICU and CCU 14:603-608,1990

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who maintained a Richmond Agitation-Sedation score =0, -1, -2		Continuously from 1 hour before extubation or end of propofol infusion before extubation, whichever is later, to 1 hour after extubation
Secondary	Variations in vital signs (blood pressure and heart rate) in patients		From 10 minutes before extubation to 10 minutes after extubation
Secondary	Percentage of patients who required analgesia and received supplemental fentanyl before and after extubation		From 7 days prior to surgery to the start of surgery, and from the end of surgery to 48 hrs after the start of infusion
Secondary	Percentage of patients with a total score of 3 on the Behavioral Pain Scale just before extubation		10±2 minutes before extubation, 2±1 minutes after extubation
Secondary	Percentage of patients who required supplemental sedation after extubation		After extubation to 24 hours after the start of study drug infusion.
Secondary	Percentage of patients who require post-extubation analgesia and who received supplemental fentanyl after extubation		After extubation to 24 hours after the start of study drug infusion.
Secondary	Amount of supplemental fentanyl required after extubation		After extubation to 24 hours after the start of study drug infusion.
Secondary	Ratio of time with a Richmond Agitation-Sedation score =+1		From 1 hour before extubation or the end of propofol infusion before extubation, whichever was later, to 1 hour after extubation
Secondary	Distribution of Richmond Agitation-Sedation score most frequently recorded while intubated		From the start of study drug administration to 1 hour before the expected time of extubation.
Secondary	Ease of patient management on the basis of a questionnaire to physicians and nurses		Conducted to the greatest possible extent, at ICU discharge or at 36 hours after the start of drug administration, whichever is earlier (in Part II only).
Secondary	Assessment of interactions between dexmedetomidine and propofol or fentanyl		After propofol or fentanyl administration (Pre-dose and Post dose [5 and 10 minutes])
Secondary	Patient self-evaluation of experiences during their stay in the ICU		Conducted to the greatest possible extent, at ICU discharge or at 36 hours after the start of drug administration, whichever is earlier (in Part II only).