TO CHECK WHETHER NEWLY INTRODUCED HEAVY ROPIVACAINE PROVIDES ANY ADDITIONAL BENEFITS OF EFFECTS ON HEART SYSTEM WHEN USED IN PLACE OF TRADITIONALLY USED HEAVY BUPIVACAINE FOR SPINAL ANAESTHESIA IN PATIENTS POSTED FOR KIDNEY STONE SURGERY

Not yet recruiting

• Conditions: Calculus of kidney,

• Registration Number: CTRI/2022/11/047164
• Lead Sponsor: Netaji Subhash Chandra Bose Superspeciality Hospital

Brief Summary

**Introduction**:

Anaesthesia is a medical field which encompasses around the safety and well- being of a patient scheduled for surgery. Therefore recent advances and researches focus on trials based on drugs and anaesthetic techniques in favour of patient care and comfort. With this perspective, Ropivacaine is a local anaesthetic agent under constant trial as it has shown to result in promising results when used in place of bupivacaine in terms of hemodynamic stability in spinal anaesthesia. The pure S-enantiomer Ropivacaine, is associated with decreased cardiotoxicity as compared to Bupivacaine. Bupivacaine is 50:50 racemic mixture of R and S- enantiomer. The undesired cardio toxic property is due to the R isomer which has more affinity for voltage gated sodium channels. Ropivacaine has lower lipid solubility, it penetrates to a lesser extent into the large myelinated nerve fibres resulting in less motor blockade than Bupivacaine  thus rendering it to be more safer drug. Initially, the effects of isobaric Ropivacaine along with various adjuvants for example fentanyl was used intrathecally to compare with hyperbaric bupivacaine in lower limb surgeries and various url-surgeries requiring subarachnoid block. with time various authors started to experiment with the basicity of the drug by pairing with dextrose in order to achieve an efficacy close to hyperbaric Bupivacaine.



**method of study :**

This study will be conducted at Netaji Subhash Chandra Bose superspeciality medical college Jabalpur after approval. This prospective, randomised, double blind study will enrol 80 patients of ASA grade 1 & , fulfilling the inclusion criteria as mentioned earlier, after written and informed consent from each participant. they will be randomly divided into two groups of 40 each.

In the operation theater a large bore IV access will be secured and 0.9% normal saline will be started. 5 lead ECG, Non invasive blood pressure, SpO2  monitoring will be recorded as baseline thereafter monitored continuously (except NIBP at every 5 minute interval).



Spinal anaesthesia will be administered using 25 gauge spinal needle (Quincke) and 4ml of trial drug or control drug (unknown to participant and investigator).

Once spinal anaesthesia is delivered, patient is immediately positioned supine and hemodynamics  including mean arterial pressure , blood pressure and heart rate  will be recorded every 2 minutes for first 10 minutes, every 10 minutes till the end of surgery.



Post operatively haemodynamic parameters will be recorded every hour for 4 hours, thereafter every 4 hours till 24 hours from time of induction of anaesthesia.

Along with the haemodynamic parameters  adverse effects such as nausea, vomitting and shivering commonly noted post spinal anaesthesia will also be recorded. Also the level of sensory and motor block including its time taken for  onset and regression will be recorded after induction to time of complete recovery from anaesthesia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-05-11
• Study Start: 2022-11-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

ASA1-2 PATIENTS POSTED FOR PERCUTANEOUS NEPHROLITHOTOMY UNDER SPINAL ANAESTHESIA.

Exclusion Criteria

PREGNANT PATIENTS ALLERGY TO EITHER DRUGS USED IN THE STUDY EMERGENCY CASES PATIENT REFUSAL TO PARTICIPATE IN THE STUDY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the following parameters in patients receiving either 0.75% Ropivacaine heavy or 0.5% Bupivacaine heavy intrathecally for subarachnoid block:	hemodynamics - fall more than 20% of baseline | drug volume - 4ml of either drug | duration of block - varies
-intra-operative haemodynamic response	hemodynamics - fall more than 20% of baseline | drug volume - 4ml of either drug | duration of block - varies
- intra-operative side effects	hemodynamics - fall more than 20% of baseline | drug volume - 4ml of either drug | duration of block - varies
- efficacy of the drug volume	hemodynamics - fall more than 20% of baseline | drug volume - 4ml of either drug | duration of block - varies
-Onset and duration of sensory and motor block	hemodynamics - fall more than 20% of baseline | drug volume - 4ml of either drug | duration of block - varies

Secondary Outcome Measures

Name	Time	Method
to compare anaesthetic effects of ropivacainein subarachnoid block with bupivacaine in patients undergoing percutaneous cystonephrolithotomy under spinal anaesthesia (PCNL)	duration of the surgery

Trial Locations

Locations (1)

NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE, SUPERSPECIALITY BLOCK; 🇮🇳 Jabalpur, MADHYA PRADESH, India

NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE, SUPERSPECIALITY BLOCK

🇮🇳Jabalpur, MADHYA PRADESH, India

JOTI KANOUJIYA

Principal investigator

919890324811

jotikanojiya@gmail.com