CTRI/2019/05/019341Not yet recruitingPhase 1/2
A prospective randomized controlled trial to compare the efficacy and safety of different doses of clonidine when used as an adjuvant to intrathecal bupivacaine
J J hospital1 site in 1 country90 target enrollmentStarted: January 6, 2019Last updated:
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Block height
Study Overview
Brief Summary
Spinal anesthesia has been the technique of choice for lower limb and abdominal surgeries and is preferred over general anesthesia. Many adjuvants have been studied to prolong the duration of action of spinal anesthesia. In our study we would like to study the effects of adding different doses of clonidine as a adjuvant to bupivacaine in subarachnoid block and observe the effects and adverse events
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I or II normotensive patients undergoing elective orthopaedic surgery.
Exclusion Criteria
- •ASA III & above, patients with cardiovascular, renal, liver dysfunction, allergy to clonidine or bupivacaine, short height (<130cm), obese(BMI > 30kg/m2) or with contraindication to spinal.
Outcomes
Primary Outcomes
Block height
Time Frame: 1year
Duration of analgesia/sensory block
Time Frame: 1year
Hemodynamic variations-pulse, MAP
Time Frame: 1year
Complications
Time Frame: 1year
Secondary Outcomes
- Hemodynamic effects-pulse and MAP(Complications)
Investigators
Study Sites (1)
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