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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01517932
Other study ID # TJMU-A-201106
Secondary ID
Status Completed
Phase Phase 4
First received January 22, 2012
Last updated March 18, 2013
Start date June 2011
Est. completion date December 2011

Study information

Verified date March 2013
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.

In this prospective, randomized, double-blind, placebo-controlled study,we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.


Description:

Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- American Society of Anaesthesiologists Physical Status (ASA-PS) I or II

- undergoing selective thoracotomy

- weight between 45 and 75kg

- operation time 2-4 hours

Exclusion Criteria:

- history of neurologic disease

- history of chronic analgesics intake

- history of allergic reactions to the experimental durgs

- history of renal insufficiency

- history of hepatic dysfunction

- history of coagulation disorders

- women in lactation

- participating in other studies

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
dexmedetomidine
In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82µg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction. Anaesthesia was maintained with propofol(4-6mg kg-1h-1),remifentanil (0.1-0.2 µg kg-1 min-1)and sevoflurane(1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46. Patients in this arm received dexmedetomidine 0.2µg/kg i.v. during 10 minutes 1 hour before the end of surgery
saline placebo
In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82µg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction. Anaesthesia was maintained with propofol(4-6mg kg-1h-1),remifentanil (0.1-0.2 µg kg-1 min-1)and sevoflurane(1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46. Patients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fang Luo

Outcome

Type Measure Description Time frame Safety issue
Primary Emergence agitation Emergence agitation was assessed by the highest restlessness score(RS)during 0-3 postoperative hours during 0-3 postoperative hours Yes
Secondary Postoperative pain at rest The patients were instructed to give the number that represented the pain level at rest by using visual analogue scale(VAS)and prince-henry score At 1,3 postoperative hours Yes
Secondary dosage Dosage of analgesics during 3 postoperative hours Yes
Secondary Recovery time At the moment of the eyes opend when calling the names Yes
Secondary Postoperative sedation It was assessed by Ramsay Sedation Score(RSS) at 0,1,3 postoperative hours Yes
Secondary Extubation time at the moment of extubation Yes
Secondary Breathing recovery time when autonomous respiration recovered Yes
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