To study the efficacy of Dexmedetomidine as an adjuvant to hyperbaric preparations of 0.5% Levobupivacaine, 0.75% Ropivacaine & 0.5% Bupivacaine in the patients undergoing surgeries under subarachnoid block
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Onset, peak & level of Sensory block ( in seconds)
Study Overview
Brief Summary
To evaluate and compare the analgesic effect of addition of Dexmedetomidine as an adjuvant to hyperbaric preparations of 0.5% Levobupivacaine, 0.75% Ropivacaine and 0.5% Bupivacaine in the patients undergoing lower abdominal and lower limb surgeries under subarachnoid block and also to study the side effects and complications if any, intraoperatively as well as post operatively.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Consent from patients and ASA grading I-II posted for lower abdominal and lower limb surgical procedures planned under subarachnoid block.
Exclusion Criteria
- •Non consenting as well pregnant patients, any spinal deformities, infection at the site,uncontrolled co-existing systemic and metabolic diseases, history of alcohol abuse, known sensivity to any LAAs and dexmedetomidine shall be excluded from the study , patients on beta blockers and sinus bradycardia.
Outcomes
Primary Outcomes
Onset, peak & level of Sensory block ( in seconds)
Time Frame: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Onset, peak & level of Motor block ( in seconds)
Time Frame: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Total duration of Analgesia (in minutes)
Time Frame: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Time for rescue Analgesia (in minutes)
Time Frame: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Total doses & amount (in mg ) of rescue analgesia
Time Frame: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2)
Time Frame: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Secondary Outcomes
- To find out side effects & complications, if any.(VAS monitoring continued every 6 hours for next 24 hours.)