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CTRI Number  CTRI/2024/01/061181 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 01/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing the effect of Fentanyl and Dexmedetomidine with Ropivicaine 0.75% Heavy in Spinal Anaesthesia for Lower Abdominal Surgeries  
Scientific Title of Study   Comparative study of Analgesic Efficacy of Fentantyl and Dexmedetomidine as adjuvant to Intrathecal Hyperbaric Ropivicaine 0.75% for Lower Abdominal Surgeries - A Prospective Double Blinded Randomised Controlled Study  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rishi S Prasad  
Designation  Junior resident  
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074 Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9901292059  
Fax    
Email  rishi1126@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Rishi S Prasad  
Designation  Junior resident  
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074 Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9901292059  
Fax    
Email  rishi1126@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ashwini H 
Designation  Professor 
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074 Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  8971265579  
Fax    
Email  drashwinih@rediffmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical College and Hospital ,Kambipura Mysore Road Bangalore Karnataka 560074  
 
Primary Sponsor  
Name  Rajarajeswari medical college and hospital 
Address  Kambipura Mysore Road Bangalore Karnataka 560074 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rishi S Prasad  Rajarajeshwari medical college and hospital  2nd floor Department of anaesthesia kambipura Mysore Road Bangalore Karnataka 560074
Bangalore
KARNATAKA 
9901292059

rishi1126@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ropivicaine with dexmedetomidine   Ropivacaine 0.75% Heavy 3ml with Dexmedetomidine 10mcg. Total volume made 3.5ml by addition of sterile normal saline. Route Intrathecal Frequency- single shot spinal anaesthesia Duration 24 hours post operative  
Intervention  Ropivicaine with fentanyl   Ropivacaine 0.75% Heavy 3ml with Fentanyl 25mcg. Total volume 3.5ml. Route Intrathecal Frequency- single shot spinal anaesthesia Duration 24 hours post operative  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA I and II patients of either sex.
2.Patients aged between 18 to 60 years
3.Patient height 0f 150cm to 170 cm
4.Patient undergoing elective lower abdominal surgeries
 
 
ExclusionCriteria 
Details  1.patient refusal
2.allergy to any of the study drugs
3.any contraindications for spinal anaesthesia
4.obesity with weight more than 100 kgs
5.height more than 170cms or less than 150 cms
6.mentally retarded patients
7.pregnant and lactating women
8.abnormalities of spine
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess the duration of analgesia defined as the time from intrathecal administration of study drug to first request for rescue analgesia.
2.To assess the duration of motor blockade, defined as the time from onset of motor blockade to complete motor recovery when Bromage scale will be “0”
 
24 hours post operation 
 
Secondary Outcome  
Outcome  TimePoints 
1.Cumulative analgesic consumption in 24 hours.
2.Maximum VAS pain score.
3.Incidence of hypotension, bradycardia, respiratory depression
 
24 hours post operation  
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Spinal anaesthesia is the most commonly performed anaesthetic technique for lower abdominal and lower limb surgery. . Many adjuncts like fentanyl, alpha 2 agonists , neostigmine, magnesium sulphate, vasoconstrictors and midazolam  have been used successfully to prolong the duration of spinal anaesthesia.

Ropivicaine, an amide local anaesthetic, with similar properties like bupivacaine, with less cardiovascular toxicity. Intrathecal isobaric ropivicaine alone produces a sensory block with variable duration of analgesia. By making ropivacaine hyperbaric and addition of adjuvants have been tried to improve the quality of intraoperative anaesthesia and postoperative analgesia.

Dexmedetomidine, a highly selective alpha 2 adrenergic agonist with antinociceptive action for both somatic and visceral pain, has been used as adjuvants to Intrathecal local anaesthetics.

Fentanyl, is a potent lipophilic synthetic opiod with a rapid onset of action and lesser incidence of respiratory depression. It has been shown to prolong the duration of analgesia in the early postoperative period.

There are limited studies on intrathecal hyperbaric ropivacaine in combination with Fentanyl or Dexmedetomidine for postoperative analgesia following lower abdominal surgeries.

This study is undertaken to compare the safety, quality and efficacy of intrathecal of Dexmedetomidine 10 mcg with hyperbaric 0.75% Ropivacaine 3ml, with that of Intrathecal Fentanyl 25 mcg with hyperbaric 0.75% Ropivacaine 3ml.

After obtaining the Institutions Ethical committee approval a comparative study  and a written  informed consent will be taken. 

Visual analogue scale for pain assessment will be explained to the patients. It’s a scale in which “0” indicates no pain and “10” indicates severe pain. 

Randomization will be done by computer generated data.

All patients will receive Alprazolam tablet at a dose of 0.5 milligrams, and Pantaprazole tablet at a dose of 40 milligrams in the night before surgery. Patients will be kept nil oral for a period of 8 hours preoperatively.

On reaching the operation theatre, and confirming the fasting status, an 18 gauge cannula will be secured to the non-dominant hand. Routine monitors will be connected.  Patient will be preloaded with Lactated Ringers solution at the rate of 10ml/kg.

Under proper aseptic conditions, spinal anaesthesia will be performed at the level of L3-L4 or L4-L5 interspace in sitting position using a midline approach by a 25G Quincke spinal needle.

Group D: patients will receive intrathecal ropivacaine 0.75% heavy 3ml with dexmedetomidine 10mcg. Total volume made 3.5ml by addition of sterile normal saline.

Group F: patients will receive intrathecal ropivacaine 0.75% heavy 3ml with fentanyl 25mcg. Total volume 3.5ml.

 The study drug will be injected slowly over 10-15 seconds with the bevel of the needle pointing upwards and the patients will be made supine immediately. Anaesthesiologist involved in preparation and administration of drug will not be involved in assessment. Assessment will be done by another anaesthesiologist who will be blinded to the group allocation.

After completion of intrathecal administration, sensory levels are assessed by loss of sensation to pin prick using 23G hypodermic needle on each dermatome for every one minute. Onset of analgesia is defined as the time taken for the block to reach T10 dermatomal level and noted. After that analgesia will be checked every 2 mins till the highest level stabilizes for 4 consecutive tests. Onset of motor blockade is defined as the time taken for the block to attain modified bromage scale grade 1. Time taken for the block to achieve modified bromage grade 3 will also be noted.  

Patients will be monitored   for heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation, Ramsay sedation scale, at intermittent intervals of 2 minutes for the first 6 minutes, 5 minutes for the next 15 minutes, 30 minutes for the next 90 minutes and half hourly henceforth .  Any adverse events like Hypotension , Bradycardia, nausea, vomiting, respiratory depression, shivering, pruritis also will be noted.

Patient will also be assessed for regression of the block by 2 dermatomal segments, and time will noted.

After the surgery, patient will be shifted to post anaesthesia care unit, where they remain till complete recovery of sensory and motor blockade. Pain will be assessed according to VAS at 2nd,4th,6th,8th,12th,24th hrs postoperatively. Time of request for rescue analgesia in the postoperative period will be noted. Duration of analgesia is defined as the time from completion of injection of study drug to the time of first request of rescue analgesia. Patients with VAS score more than 5 will receive inj Tramadol 1mg/kg body weight. If pain persists after 10 minutes of tramadol, patients will receive inj Dicolfenac 1 mg/kg body weight. Total analgesic consumption in 24 hrs will be noted. Motor recovery will also be assessed half hourly until modified bromage grade 0 is achieved. . Time to void urine will also be noted. 


 
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