| 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
|
|
|
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
|
|
|
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
|
|
|
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 Anesthesiologyâ€, 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. |