comparing the effect of 4ml of 0.75% of isobaric Ropivacaine alone or with 5µg dexmedetomidine for abdominal hysterectomy Under spinal anesthesia

Recruiting

• Conditions: ASA GRADE 1 AND 2 All patients having age between 30 to 60 yr weight 40 to 80 kg and height more than 140cm will be included

• Registration Number: CTRI/2017/11/010704

Brief Summary

Ropivacaine, first levo-isomer an amide local anaesthetic shares many physiochemical properties with bupivacaine but has shown a better safety profile over bupivacaine due to the reduced central nervous system and cardiac toxicity.(5,6) Recent clinical data have shown that ropivacaine is clinically effective and safe for regional anaesthetic techniques with good tolerability. Ropivacaine has been successfully used in spinal anaesthesia for caesarean section, urological surgery, and lower limb orthopedic surgery. However there is scarcity of data in which ropivacaine has been used in SAB for abdominal hysterectomy in which there is more extensive surgery, needing more relaxation than above mentioned surgeries. This prompted us to plan present study.When dexmedetomidine added to intrathecal ropivacaine better clinical profile was noted as compared to ropivacaine alone. However, no study comparing efficacy of ropivacaine 4ml of 0.75% versus ropivacaine 0.75% plus 5µg dexmetomedine in spinal anesthesia has been conducted to date.

 Therefore we are planning present study using 4 ml of 0.75% ropivacaine alone and with 5µg dexmedetomidine   in spinal anesthesia for abdominal hysterectomy, to study sensory and motor block characteristics, success rate, postoperative analgesia, haemodynamic profile, and complications.

Patients who will fulfill inclusion criteria will be enrolled in the study prior to enrolment written and informed consent will be taken. these patients will be randomly divided into two groups of 45 patients in each group using sealed envelope technique:

•   Group R: Patients will receive 4ml (30mg) of 0.75% Isobaric Ropivacaine hydrochloride.

•   Group RD: Patients will receive 4ml (30mg) of 0.75% Isobaric Ropivacaine with 5µg dexmedetomidine hydrochloride (0.05ml)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

All ASA GRADE 1 AND 2 patients having age between 30 to 60 year weight 40 to 80 kg and height more than 140cm will be included.

Exclusion Criteria

• Patient refusal.
• Contraindication to regional anaesthesia.
• History of significant co-existing diseases like ischemic heart disease, hypertension, impaired renal functions, rheumatoid arthritis, severe liver disease and morbid obesity.
• Atrio-ventricular block, incomplete or partial heart block.
• Intake of α or β blockers.
• Presence of anaemia, fused spine, coagulation disorder, diabetes, psychiatric illness, thyroid disease and malnourished patient,.Patient on any medication for systemic disease.
• Allergy to amide local anaesthetics and dexmedetomidine.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Efficacy of Isobaric Ropivacaine 0.75%,4ml Alone and with Dexmedetomidine in Spinal Anaesthesia for Abdominal Hysterectomy	six months period

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

RNT Medical College And Attached Hospital Udaipur; 🇮🇳 Udaipur, RAJASTHAN, India

RNT Medical College And Attached Hospital Udaipur

🇮🇳Udaipur, RAJASTHAN, India

DR BABU LAL JAT

Principal investigator

7742018002

blghoshliya2@gmail.com