Pain, Restlessness
Conditions
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
Interventions
DRUGdexmedetomidine
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
DRUGsaline 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
Sponsors
Fang Luo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence agitation | during 0-3 postoperative hours | Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dosage Dosage of analgesics | during 3 postoperative hours | — |
| Recovery time | At the moment of the eyes opend when calling the names | — |
| 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 |
| Extubation time | at the moment of extubation | — |
| Breathing recovery time | when autonomous respiration recovered | — |
| Postoperative sedation | at 0,1,3 postoperative hours | It was assessed by Ramsay Sedation Score(RSS) |
Outcome results
None listed