Comparison of effects of different doses of dexmedetomidine as an intrathecal adjuvant to hyperbaric ropivacaine in lower abdominal surgeries : a prospective randomised controlled study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1.To asses onset and duration of sensory blockade from the time of drug adminitration
Study Overview
Brief Summary
This is a prospective randomized controlled study to compare the effects of different doses of dexmedetomidine that is 5, 10, 15 and 20mcg as an intrathecal adjuvant to hyperbaric ropivacaine in elective lower abdominal surgeries. Total sample size id 100, divided into 5 groups including the control group. Primary objective is to asses the onset and duration of sensory blockade, time for 2 segment sensory regression, onset and duration of motor blockade and time of rescue analgesia. Secondary objective include monitoring of hemodynamics and adverse effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All ASA Grade 1 and 2, patients scheduled for elective lower abdominal surgery under subarachnoid block.
Exclusion Criteria
- •Patients with hypertension, diabetes, spinal deformity, coagulation disorder, drug allergy, cardiovascular , respiratory or neurological disorders, pregnant patients, height less than 140cm, BMI more than 30kg per meter square, impaired liver and renal function tests, ASA Grade 3, 4, local skin infections.
Outcomes
Primary Outcomes
1.To asses onset and duration of sensory blockade from the time of drug adminitration
Time Frame: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
2. Maximum sensory level achieved and time taken for it
Time Frame: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
3.Time taken for 2 segment sensory regression
Time Frame: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
4. Onset and duration of motor blockade
Time Frame: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
5. Total duration of post op analgesia
Time Frame: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
Secondary Outcomes
- Changes in hemodynamic parameters and adverse effects(24 hours after spinal anaesthsia)
Investigators
Simran Naval
Mysore Medical College and Research Institute