A Comparative Study Of Prophylactic Intravenous Ondansetron On Spinal Anaesthesia Induced Hypotension Versus Placebo.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- 1)To study the effect of ondansetron for prevention of spinal anesthesia induced hypotension.
Study Overview
Brief Summary
The present study is a Prospective, Randomized Double Blind study done after approval of Institutional Ethics Committee satisfying all inclusion and exclusion criteria planned for any non-obstetric surgery under spinal anaesthesia.
Material used were Quincke type spinal needle of 25 gauge, Sterile 5 cc and 10 cc syringes. Bupivacaine 0.5% Heavy ampoule, Injection Ondansetron 8mg/4ml ampoule, Injection Atropine , Injection Mephenteramine, Emergency drugs, IV Fluids, Anaesthesia workstation, suction apparatus Laryngoscope and ET Tubes of various sizes.
After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient.
Anesthesiologist blinded to the prepared drug solution slowly administered 10 ml solution over 10 seconds. After 5 minutes, spinal anaesthesia will be performed in L3-L4 interspace with 25 G Quincke’s spinal needle using 3.0 ml of 0.5% heavy bupivacaine in sitting position. Patient will be immediately placed in supine position. SBP, DBP, MAP, HR and oxygen saturation will be recorded in individual proforma at the time of spinal anaesthesia and then at an interval of three minutes up to 15 minutes and then every 5minutes. Patients developing the primary endpoint of hypotension (systolic blood pressure 20% in baseline values) will be treated with injection mephentermine 6 mg IV, and those developing bradycardia (heart rate<50bpm) will be treated with injection atropine 0.6mg IV. Surgery will be allowed to start once sensory and motor blockade is achieved.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Any patient going for non-obstetric surgery under spinal anesthesia 2) American Society of Anesthesiologists (ASA) Grade I or II 3) BMI 18.5-24.9kg/m2.
Exclusion Criteria
- •Patient refusal
- •Pregnant patients.
- •Any contraindication of spinal anesthesia.
- •Any spinal deformity.
- •Any patient with known hypersensitivity to ondansetron
- •Patients with comorbidities like diabetes, hypertension, asthma, tuberculosis.
- •Patients with conduction block.
- •Patient converted to general anesthesia.
Outcomes
Primary Outcomes
1)To study the effect of ondansetron for prevention of spinal anesthesia induced hypotension.
Time Frame: Till 60 mins post operatively.
Secondary Outcomes
- 1) To evaluate the beneficial effects of ondansetron.(2) To study the advantage of pre loading in patients going for surgery under spinal anesthesia.)
Investigators
Dr Bandini Singhal
Government Medical College,Haldwani