Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

Phase 4

Completed

• Conditions: Restlessness; Pain
• Interventions: Drug: dexmedetomidine; Drug: saline placebo

• Registration Number: NCT01517932
• Lead Sponsor: Fang Luo

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-01-22
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-DEX	dexmedetomidine	Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery
Group-PLB	saline placebo	Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery

Primary Outcome Measures

Name	Time	Method
Emergence agitation	during 0-3 postoperative hours	Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours

Secondary Outcome Measures

Name	Time	Method
Postoperative pain at rest	At 1,3 postoperative hours	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	during 3 postoperative hours
Recovery time	At the moment of the eyes opend when calling the names
Postoperative sedation	at 0,1,3 postoperative hours	It was assessed by Ramsay Sedation Score(RSS)
Extubation time	at the moment of extubation
Breathing recovery time	when autonomous respiration recovered