Anaesthetic management of high risk orthopedic patients with combined sequential spinal epidural using three different doses of intrathecal ropivacaine
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The primary objective is to compare the hemodynamic stability measured in terms of fall in MAP 30% from baseline.
Study Overview
Brief Summary
Patients will be observed in terms of 3 groups namely Group 1 SAB with three and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 2 SAB with five mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 3 SAB with seven and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achievedAfter 2 segment regression epidural top ups will be given with bupivacaine half percent either one third of the dose needed to achieve T10 level or 3 ml. The level of sensory block, modified Bromage motor scores MBS systolic blood pressure MAP and heart rate will be recorded for 30 min following anesthesia Peak sensory block height and MBS time for sensory regression to L1 and motor recovery to MBS 1 side effects and operator s satisfaction will be noted.Dural puncture will be performed at the L3 4 interspace with a 25 gauge Quincke tip spinal needle Next 0 5 percent hyperbaric ropivacaine will be given intrathecally in doses of 7 5 mg 11 25 mg and 15 mg in 3 groups namely groups 1 2 and 3 after the free flow of cerebrospinal fluid is observed The degree of sensory and motor block will be measured on the unoperated side of the limbs Surgery will be allowed to start as soon as the sensory block height reached the tenth thoracic dermatome T10 or 10 min had elapsed After 2 segment regression epidural top ups with bupivacaine 0 5 percent either 1/3 of the dose needed to achieve T10 level or 3 ml will be given,for the completion of surgery The orthopedic surgeons performing all the operations will grade the operator s satisfaction on a 5 point scale 5 very good 4 good 3 satisfactory 2 poor 1 very poor Similarly patient satisfaction will be noted down on a five point Likert scale Very satisfied Satisfied Neither satisfied nor dissatisfied Dissatisfied and Very dissatisfied from a scale of 5 to 1
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 65.00 Year(s) to 95.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with ASA III & above 2.Heart disease with systolic & diastolic dysfunction 3.IHD with no indication/unwilling for pre-procedure intervention 4.Patients of either sex above 75 yrs of age irrespective of other comorbidities 5.Patients of uncontrolled DM 6.Elective /emergency surgery.
Exclusion Criteria
- •1.Patients <65 yrs 2.Contraindication of CSEA/SAB 3.Not willing.
Outcomes
Primary Outcomes
The primary objective is to compare the hemodynamic stability measured in terms of fall in MAP 30% from baseline.
Time Frame: Every 5 minutes, upto 30 minutes and then every 15 minutes till completion of surgery.
Secondary Outcomes
- 1. Incidence of bradycardia(2. Time needed to achieve bromage 3 (complete motor paralysis))
Investigators
Sathyasuba Meenakshi sundaram
BIHER
