To compare and identify which medication among dexmedetomidine and fentanyl as additive to hyperbaric ropivacaine for spinal anaesthesia in patients undergoing removal of uterus surgery is safe and effective.
Phase 3
Completed
- Conditions
- Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified
- Registration Number
- CTRI/2024/03/064274
- Lead Sponsor
- Dr M Vivekanandh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1)patients belonging to ASA class I & class II.
2)patients without any severe comorbid diseases.
Exclusion Criteria
1)Patients having any absolute contraindications for spinal anaesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac, respiratory, and CNS diseases.
2)Pregnant females and those with chronic diseases such as diabetes, hypertension,renal dysfunction, liver disorders and cardiac abnormalities.
3)Patients with body mass index >30 kg/m².
4)Patients shorter than 150 cm.
5)Patients allergic to any of the study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine.Timepoint: comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine at baseline,at 5 minutes, then every 15 minutes till end of the surgery, and in the postoperative period till blockade regression.
- Secondary Outcome Measures
Name Time Method 1)Complete sensory & motor blockade attained & time taken for the same. <br/ ><br>2)Total duration of analgesia. <br/ ><br>3)Rescue analgesia. <br/ ><br>4)The haemodynamic changes such as hypotension & bradycardia. <br/ ><br>5)Side effects such as pruritus, nausea & vomiting, shivering. <br/ ><br>Timepoint: 1)Complete sensory & motor blockade attained & time taken for the same at 5 minutes, then at every 15 minutes till blockade regression. <br/ ><br>2)Total duration of analgesia in the postoperative period. <br/ ><br>3)Rescue analgesia. <br/ ><br>4)The haemodynamic changes such as hypotension & bradycardia occuring intraoperatively at every 15 minutes. <br/ ><br>5)Side effects such as pruritus, nausea & vomiting, shivering occuring at the end of surgery. <br/ ><br>