Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fang Luo, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01517932
First received: January 22, 2012
Last updated: March 18, 2013
Last verified: March 2013

January 22, 2012
March 18, 2013
June 2011
December 2011   (final data collection date for primary outcome measure)
Emergence agitation [ Time Frame: during 0-3 postoperative hours ] [ Designated as safety issue: Yes ]
Emergence agitation was assessed by the highest restlessness score(RS)during 0-3 postoperative hours
Same as current
Complete list of historical versions of study NCT01517932 on ClinicalTrials.gov Archive Site
  • Postoperative pain at rest [ Time Frame: At 1,3 postoperative hours ] [ Designated as safety issue: Yes ]
    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
  • dosage Dosage of analgesics [ Time Frame: during 3 postoperative hours ] [ Designated as safety issue: Yes ]
  • Recovery time [ Time Frame: At the moment of the eyes opend when calling the names ] [ Designated as safety issue: Yes ]
  • Postoperative sedation [ Time Frame: at 0,1,3 postoperative hours ] [ Designated as safety issue: Yes ]
    It was assessed by Ramsay Sedation Score(RSS)
  • Extubation time [ Time Frame: at the moment of extubation ] [ Designated as safety issue: Yes ]
  • Breathing recovery time [ Time Frame: when autonomous respiration recovered ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia
Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Restlessness
  • Pain
  • 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

    Other Name: dexmedetomidine
  • Drug: 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

    Other Name: saline placebo
  • Experimental: Group-DEX
    Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery
    Intervention: Drug: dexmedetomidine
  • Placebo Comparator: Group-PLB
    Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery
    Intervention: Drug: saline placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01517932
TJMU-A-201106
Yes
Fang Luo, Huazhong University of Science and Technology
Fang Luo
Not Provided
Study Director: Fang Luo, MD.PhD Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Huazhong University of Science and Technology
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP