Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Restlessness Pain |
Drug: dexmedetomidine Drug: saline placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period |
- 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
- 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 ]
| Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Other Name: 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
|
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
|
Detailed Description:
Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
More Information
No publications provided
| Responsible Party: | Fang Luo, Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology, Huazhong University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01517932 History of Changes |
| Other Study ID Numbers: | TJMU-A-201106 |
| Study First Received: | January 22, 2012 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Psychomotor Agitation Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013