A Prospective Randomized Study Comparing Intrathecal Dexmedetomidine and Fentanyl as Adjuvants to Hyperbaric Ropivacaine in Infra Umbilical Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Onset of sensory blockade
Study Overview
Brief Summary
Spinal anesthesia is the most preferred technique for infraumbilical surgeries. Hyperbaric Ropivacaine has been shown to produce reliable and predictable anesthesia for surgery. Fentanyl, a synthetic lipophilic opioid, and Dexmedetomidine, a new highly selective alpha 2 agonist have been used as neuraxial adjuvants in spinal anesthesia to prolong intraoperative and postoperative analgesia. This study is undertaken to investigate and compare the clinical effects of 0.75% hyperbaric ropivacaine with additives such as fentanyl and dexmedetomidine on spinal anesthesia for infraumbilical surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients belonging to ASA physical status Class I and Class Patients without any severe comorbid diseases.
Exclusion Criteria
- •Patients having any absolute contraindications for spinal anesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac, respiratory, and CNS diseases are excluded from the study Pregnant females.
- •chronic diseases such as diabetes and hypertension Patients with body mass index >30 kg/m2 Patients shorter than 150 cm.
Outcomes
Primary Outcomes
Onset of sensory blockade
Time Frame: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Maximum level of sensory blockade attained and the time taken for the same
Time Frame: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Time for two-segment sensory regression
Time Frame: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Onset and duration of motor blockade
Time Frame: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Total duration of analgesia
Time Frame: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Secondary Outcomes
- Hemodynamic changes, Adverse Effects(5min, 10min, 15min, 20min, 25min, 30min, 35min, 40min, 45min, 50min, 55min, 60min)