To compare Intrathecal Dexmeditomidine 10mcg versus Fentanyl 25mcg when added with Hyperbaric 0.75% Ropivacaine 18.75mg as additive in Spinal Anaesthesia in Patients Undergoing Infraumbilical Surgeries

Not yet recruiting

• Conditions: ,

• Registration Number: CTRI/2023/05/052458
• Lead Sponsor: Multidisciplinary Research Unit Dr SNMC Jodhpur

Brief Summary

Present Study Topic: Comparative study of Effects of Intrathecal Dexmeditomidine versus Fentanyl as adjuvants to Hyperbaric 0.75% Ropivacaine in Patients Undergoing Infraumbilical Surgeries

Aims and Objectives:

Primary Objectives:To compare the duration of Analgesia in the Intrathecal Dexmeditomidine (RD) , Fentanyl (RF),Control group (RC)

Secondary Objectives: following parameters will be compared in three groups e.g time of onset , duration and quality of Sensory blockade and Motor blockade, hemodynamic changes and side effects.

Study type: Randomized comparative study

Source of data: the study will be carried out in the department of Anaesthesiology,Dr S.N.Medical College and associated hospitals(MDM hospital,MGH hospital and Ummaid Hospital Jodhpur).

Study Duration:6months or till sample size achieved.

Sample size: Total 90 Patients (30 Patients in each group)

Study population: Study population will be randomly divided by computer generated random table and group allocation will be done by shuffled closed envelope technique into three equal groups.

1. Group(RF)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+ 25mcg Fentanyl (0.5ml)

2. Group (RD)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+10mcg Dexmeditomidine

3. Group (RC)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+0.5ml Normal saline

Inclusion Criteria and Exclusion criteria:as mentioned in above format.

Randomization:the each Patients will be received 3ml it the study drug according to randomization. Double blinding technique will be applied.hence the patient and the observer will be blinded to the study drug.

Intraoperatively and Postoperatively monitoring will be noted .

Statistical analysis:Data will be entered into Microsoft Excel data sheet and will be analysed using SPSS 22 version software.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-05
• Study Start: 2023-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Adult Patients of either sex ,aged between 18 and 60 years who will be Undergoing for infraumbilical surgeries Patients belonging to ASA-PS class1 and class 2 Patients without any severe comorbid diseases.

Exclusion Criteria

Patients having any absolute contraindications for Spinal Anaesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis,local site infection,severe cardiac , respiratory,and CNS diseases are excluded from the study Pregnant females,uncontrolled diabetes and hypertension Patients with body mass index greater than 30kg/m2 Patients shorter than 150cm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of Analgesia Postoperatively-VAS (visual analogue score) VAS equal or greater than 4 or time of first Analgesia request	Time in minutes-0,15,30,60,90,120,150,180,210,240,270,300

Secondary Outcome Measures

Name	Time	Method
Secondary Objectives	Time of onset and duration of Sensory blockade

Trial Locations

Locations (2)

MDM Hospital Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

MGH Hospital Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

MDM Hospital Jodhpur

🇮🇳Jodhpur, RAJASTHAN, India

Dr Chunnilal

Principal investigator

8209516803

drclchoudhary@gmail.com