Patients undergo lumbosacral spine surgery Nefopam
Conditions
Interventions
Placebo -
Placebo
30 min before incision and 30 min before the end of surgery
,Nefopam -
Placebo
30 min before incision and 30 min before the end of surgery,Placebo -
Nefopam
30 min before incision and 30 min before the end of surgery,Nefopam -
Nefopam
30 min before incision and 30 min before the end of surgery
Placebo,Nefopam -
Placebo,Placebo -
Nefopam,Nefopam -
Nefopam
Sponsors
Department of Medical Services
Department of Medical Services
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age ≥ 18 years 2. Scheduled for lumbosarcral spine surgery under general anesthesia 3. ASA physical status I - III 4. Operation time 4 - 6 hours 5. Not known allergy to morphine and nefopam
Exclusion criteria
Exclusion criteria: 1. Current nefopam use within 24 hours prior to study 2. Previous history of cardiovascular disease 3. Previous history of epilepsy 4. Previous history of liver disease 5. Previous history of chronic opioids therapy > 2 weeks 6. Previous history of chronic Monoamine oxidase inhibitors (MAOIs) therapy > 2 weeks 7. Unable to use patient controlled analgesia (PCA) device 8. Creatinine clearance < 30 mL/min (calculated by the Cockcroft-Gault equation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| analgesic efficacy of nefopam and placebo 24-hour postoperatively morphine consumption (mg) | — |
Secondary
| Measure | Time frame |
|---|---|
| the safety of nefopam 24-hour postoperatively incidence of tachycardia, sweating, sedation, nausea or vomiting | — |
Countries
Thailand
Contacts
Public ContactJatuporn Eiamcharoenwit
Department of Anesthesiology, Prasat Neurological Institute
Outcome results
None listed