A comparative study of post operative analgesia using intra thecal Dexmedetomidine and fentanyl as adjuvant to bupivacaine in lower abdominal surgeries. A Randomized double blinded study
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Konjengbam Reshmi Devi
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To compare the duration of postoperative Analgesia (demand of first rescue analgesia)in first 24 hours
Overview
Brief Summary
The study will be a prospective randomized double-blinded study to assess and compare the effects of intrathecal administration of low dose of 10mg hyperbaric Bupivacaine with 5 mcg dexmedetomidine and 10 mg hyperbaric Bupivacaine with 12.5 mcg fentanyl. A total of 60 patients will be selected for the study and divided into 2 groups of 30 patients each Group A (n-30) and Group B (n-30). According to a computer-generated randomization table, patients in group A will be administered 2 ml of 0.5% bupivacaine heavy and 0.5ml (12.5µgm) fentanyl citrate and group B will be administered 2 ml of 0.5% bupivacaine heavy and 0.1 ml of 5 mcg dexmedetomidine in the subarachnoid space L3-L4. In both the groups, the study drugs will be administered at a rate of 0.2 ml/min. in the subarachnoid space L3-L4. The block characteristics along with regression of the blockade, side effects (if any) and the hemodynamic changes will be observed, assessed and recorded by blinded investigator using the VAS and sedation scale. The finding and observation made during the entire study will be tabulated graphically depicted whenever possible, statistically analysed and inference will be drawn to evaluate the duration of post-operative analgesia and side effects of the two study drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American Society of Anaesthesiologists (ASA) physical status I and II.
- •18- 65 years of age.
- •Either sex.
Exclusion Criteria
- •History of allergy to study drugs
- •Bleeding disorder
- •Local site infection
- •Cardiac,respiratory and kidney disorder,neurological deficit 5.Spinal deformity.
Outcomes
Primary Outcomes
To compare the duration of postoperative Analgesia (demand of first rescue analgesia)in first 24 hours
Time Frame: Outcome will be assessed at 24 hours post-op
Secondary Outcomes
- 1. Hemodynamic parameters- Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (spo2)(2. Adverse effects.)
Investigators
Konjengbam Reshmi Devi
Regional Institute of Medical Sciences, Imphal