| CTRI Number |
CTRI/2023/10/059118 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of Intravenous Fentanyl vs Intravenous Dexmedetomidine on Characteristics of Spinal Anaesthesia |
|
Scientific Title of Study
|
COMPARISON OF EFFECT OF IV FENTANYL VS IV DEXMEDETOMIDINE ON CHARACTERISTICS OF SPINAL ANAESTHESIA |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical College Hospital & Research Centre |
| Address |
Department of Anaesthesia
Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
Sant Tukaram Nagar
Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422710943 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical College Hospital & Research Centre |
| Address |
Department of Anaesthesia
Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
Sant Tukaram Nagar
Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422710943 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Runjhun Jain |
| Designation |
Junior Resident |
| Affiliation |
Dr. D. Y. Patil Medical College Hospital & Research Centre |
| Address |
Department of Anaesthesia
Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
Sant Tukaram Nagar
Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9008759085 |
| Fax |
|
| Email |
jainrunjhun@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, High Tech Building, Fifth floor, Dr D.Y Patil Medical College and Research Centre, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Runjhun Jain |
| Address |
Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH
CENTRE Sant Tukaram Nagar Pimpri Pune |
| Type of Sponsor |
Other [] |
|
|
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 Aparna Bagle |
Dr. D. Y. Patil Medical College Hospital and Research Centre, Pimpri, Pune |
OT Complex, Fifth floor, High Tech Building, Sant Tukaram Nagar, Pimpri
Pune
MAHARASHTRA |
9422710943
draparnabagle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr. D.Y. Patil Medical College, Hospital and Research Centre |
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 |
| Intervention |
Intravenous Dexmedetomidine |
Intravenous Injection Dexmedetomidine 0.5 mcg/kg (diluted to 10 ml with normal saline) over a period of 10 min as premedication 5 min before spinal anaesthesia |
| Comparator Agent |
Intravenous Fentanyl |
Intravenous Injection Fentanyl 1 mcg/kg (diluted to 10 ml with normal saline) over a period of 10 min as premedication 5 min before spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I or II fit patients. Ages between 18 and 65 years of either gender. Patients posted for infra umbilical surgery under sub-arachnoid block. Availability of informed consent |
|
| ExclusionCriteria |
| Details |
Patients with ASA physical status III or more. Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic disease or with coagulation abnormalities. Patients with contraindication for spinal anaesthesia. Patients with known allergies to the study drug. Patient refusal. Patients below 18 years and above 65 years of age |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to achieve sensory blockade at T10, Time to achieve complete motor block, Highest level of sensory blockade achieved, Intraoperative hemodynamic parameters, Ramsay sedation score, Regression of spinal anaesthesia by two segments |
Basic vital parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, oxygen saturation & Ramsay sedation score will be recorded. Then, these will be recorded after dural puncture & every 5 min for 15 min & then every 15 min interval till the end of surgery after spinal anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of requirement of the first dose of postoperative rescue analgesic |
1 hour, 2 hour, 4 hour, 8 hour, 12 hour & 24 hour after administration of Sub Arachnoid Block |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
06/11/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective, randomized, double blind, comparitive study. It is to study the effect of intravenous Fentanyl ( 1 mcg/kg ) vs intravenous Dexmedetomidine ( 0.5 mcg/kg) on characteristics of spinal anaesthesia to observe and compare the following parameters: 1. Time to achieve sensory blockade at T10 2. Time to achieve complete motor block 3. Highest level of sensory blockade achieved 4. Intraoperative hemodynamic parameters 5. Ramsay sedation score 6. Regression of Spinal Anaesthesia by two segments 7. Time to first rescue analgesia ( Duration of analgesia ) |