Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

Pain Clinical Trial

Official title:

Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517932
• Other study ID #: TJMU-A-201106
• 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

• Pain
• Restlessness

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