Clinical trial the effect of intrathecal opioid on bispectral index in patient with lower limb orthopedic surgery under spinal anesthesia.
Phase 4
Completed
- Conditions
- sedation in spinal anesthesia.Unspecified adverse effect of drug or medicament
- Registration Number
- IRCT2016080627677N4
- Lead Sponsor
- Vice Chancellor for research of Urmia University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
physical status class I from the perspective of America society of Anesthesiologists; lower limb orthopedic surgery with spinal anesthesia; Lack of opioid addiction
Exclusion criteria:
spinal anesthesia contraindications; any unusual complications including a lot of bleeding during surgery; prolonged surgery
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel of consciousness. Timepoint: Bispectral index will be recorded at baseline and 5, 10, 15, 30, 45 and 60 minutes after spinal injection. Method of measurement: Bispectral Index Monitoring.
- Secondary Outcome Measures
Name Time Method Mean Arterial Blood Pressure. Timepoint: Mean Arterial Pressure will be recorded 5, 10, 15, 30, 45 and 60 minutes after spinal injection at baseline. Method of measurement: None Invasive Blood Pressure.;Heart Rate. Timepoint: Heart Rate will be recorded 5, 10, 15, 30, 45 and 60 minutes after spinal injection at baseline. Method of measurement: Electrocardiogram.