A Randomized Comparative Study to Evaluate The Effects and Safety of Intrathecal Hyperbaric Levobupivacaine 0.5% and Hyperbaric Ropivacaine 0.75% In Patients Undergoing Transurethral Resection of Prostate(TURP) Surgery under Spinal Anaesthesia
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Karan Malhotra
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The objective of the study is to evaluate the efficacy in terms of onset and duration of sensory block as primary outcome in two groups: Group 1(L) – 3ml 0.5% hyperbaric levobupivacaine and Group 2(R) – 3ml 0.75% hyperbaric ropivacaine.
Overview
Brief Summary
The present prospective, randomized and double blind study will be conducted in Department of Anaesthesiology, MMIMSR Mullana Ambala, Haryana. After the approval of protocol by the Institutional Ethics Committee, and registration with Clinical Trial Registry India, a total number of 50 ASA I and ASA II status patients scheduled for elective TURP surgery under spinal anaesthesia will be included in the study after obtaining informed consent for the study. The effects and efficacy of hyperbaric LEVOBUPIVACAINE 0.5% and hyperbaric ROPIVACAINE 0.75% will be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 0.00 Year(s) to 99.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •ASA 1 and ASA 2 patients posted for TURP.
Exclusion Criteria
- •Negative consent by the patient
- •Contraindication for spinal Anaesthesia (such as coagulopathy, infection at injection site, hypotension, disease or deformity of spine)
- •Psychiatric patient
- •ASA status III/IV
- •Known sensitivity to the drug.
Outcomes
Primary Outcomes
The objective of the study is to evaluate the efficacy in terms of onset and duration of sensory block as primary outcome in two groups: Group 1(L) – 3ml 0.5% hyperbaric levobupivacaine and Group 2(R) – 3ml 0.75% hyperbaric ropivacaine.
Time Frame: Outcomes will be assessed at baseline, time intervals of 2min upto 10min after administration of spinal anaesthesia with the selected drugs followed by every 5 minutes until completion of surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Karan Malhotra
MMIMSR, Mullana