Pain Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fang Luo |
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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