Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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
|
| 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 |
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fang Luo
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TJMU-A-201106