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CTRI Number  CTRI/2021/02/031470 [Registered on: 22/02/2021] Trial Registered Prospectively
Last Modified On: 12/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare efficacy of fentanyl versus clonidine when added to 1% chloroprocaine in patients undergoing infra-umbilical surgeries. 
Scientific Title of Study   Comparison of fentanyl and clonidine as adjuvants to intrathecal 1% chloroprocaine in infra-umbilical surgeries-A randomized comparative trial 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr DISHA PARHI 
Designation  JUNIOR RESIDENT 
Affiliation  Rohilkhand medical college and hospital 
Address  Main OT complex ,Department of Anesthesiology Rohilkhand medical college and hospital Bareilly
Department of Anesthesiology Rohilkhand medical college and hospital Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  7004946971  
Fax    
Email  dishaparhi05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Disha Parhi 
Designation  JUNIOR RESIDENT 
Affiliation  Bareilly international University 
Address  Main OT comlex department of anesthesiology Rohilkhand Medical College and hospital Bareilly
Department of Anesthesiology Rohilkhand medical college and hospital Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  7004946971  
Fax    
Email  dishaparthi05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Malti agrawal 
Designation  Professor and head 
Affiliation  Bareilly international University 
Address  Main OT complex Department of anesthesiology Rohilkhand Medical College and hospital Bareilly UP
Bareilly UP India
Bareilly
UTTAR PRADESH
243006
India 
Phone  7004946971  
Fax    
Email  dr_malti_agrawal@yahoo.com  
 
Source of Monetary or Material Support  
RMCH BAREILLY 
 
Primary Sponsor  
Name  Rohilkhand Medical College and hospital bareilly 
Address  Suresh Sharma nagar Pilibhit bypass road Bareilly 
Type of Sponsor  Private medical college 
 
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 
Dr Disha Parhi  Rohilkhand medical college and hospital  Department of Anesthesiology Rohilkhand medical college and hospital Bareilly
Bareilly
UTTAR PRADESH 
07004946971

dishaparhi05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chloroprocaine and clonidine  Chloroprocaine 30 mg clonidine 30 mcg intrathecal administration 
Intervention  Chloroprocaine and fentanyl  Chloroprocaine 30 mg fentanyl 25 mcg intrathecal administration 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  • American society of Anesthesiologists (ASA)1 grade I or II
• Between 19-65 years (adults)17,18of either sex
• Undergoing infra-umbilical surgeries will be included
 
 
ExclusionCriteria 
Details  1. Patient refusal for procedure

2.Patient’s with contraindication to spinal anaesthesia

3.Obesity (BMI>30kg/m2)

4.Any neuropathy

5.Patients receiving opioids for chronic analgesic therapy

6.Allergy or intolerance to local anaesthetics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
onset of blockade  5-10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
duration of blockade  1-2 hours 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2021 
Date of Study Completion (India) 28/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
European journal of molecular & clinical medicine ( embase indexed) vol 9 issue 4 summer 2022. ISSN 2550-8260 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

  Our research work and study was conducted in the “Department of Anesthesiology”, Rohilkhand Medical College and Hospital, following approval by the Board of Institutional Ethics Committee (IEC/04/2020/OCT) and registration of the study with Clinical Trial Registry of India (CTRI/2021/02/031470), with the objective to compare the efficacy of intrathecally administered fentanyl and clonidine as adjuvants to 1% chloroprocaine, in patients posted for elective infra-umbilical surgeries.

In our study a total of 64 patients were included which were statistically calculated using the software Power and sample size program35. The sample size was calculated as 32 in each group.35

⮚ Group C: patients were scheduled to receive 1% Isobaric Chloroprocaine 3 ml (30mg) + clonidine (30 mcg), i.e. 0.2 ml after dilution with 0.3ml of 0.9% normal saline. Total volume = 3.5ml

⮚ Group F: patients were scheduled to receive 1% chloroprocaine 3ml (30 mg) + fentanyl (25 mcg), i.e. 0.5 ml. Total volume = 3.5ml

In our study, there was no statistically significant difference (p>0.05) in demographic profile (age, weight, gender) among the groups showing comparability of the groups in respect of age, weight and gender. The mean time of onset of sensory and motor block was statistically insignificant among the groups (p>0.05). The maximum peak height achieved in both Groups was up to T6 level and these observations were statistically non-significant (p>0.05). In our study, time for 2 segment regression was observed to be earlier in group of patients who got spinal anaesthesia with Chloroprocaine along with Fentanyl. The mean duration of sensory blockade was statistically significant (p<0.001) when compared between two groups and prolonged in the group who received Chloroprocaine with Clonidine intrathecally. Onset of motor block was comparable in both clonidine and fentanyl groups and were statistically insignificant (p>0.05). But, when compared with plain local anesthetics, addition of adjuvants has shown earlier onset (as per several other studies). In our study we found mean time of total duration of motor block prolonged in group of patients who received clonidine as an adjuvant to intrathecal chloroprocaine. As per several studies, when compared with plain local anesthetics, addition of adjuvants has shown prolonged duration of sensory as well as motor block. While clonidine as an adjuvant gave longer duration of sensory as well as motor blockade than that of fentanyl as an adjuvant to intrathecal chloroprocaine or other local anesthetics. Patients who received fentanyl as an adjuvant to intrathecal chloroprocaine were found to be more hemodynamically stable in intra-operative period than in patients who received clonidine as an adjuvant to intrathecal chloroprocaine. Few patients in both the groups had episodes of hypotension and bradycardia which was managed well as per study protocol. Transient neurological symptoms, respiratory depression and pruritis was not seen in any of the groups. Our observations on side effects were found to be statistically insignificant (p>0.05) on comparison between both groups. Patients in fentanyl group were found to be more hemodynamically stable in intra-operative and post-operative period than in clonidine; but lesser side effects like PONV (post operative nausea and vomiting), shivering etc. was seen in patients who received clonidine as an adjuvant to intrathecal chloroprocaine.

 
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