| CTRI Number |
CTRI/2025/12/098565 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| 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
|
Comparison of Intrathecal Fentanyl and Dexmedetomidine with Low Dose Levobupivacaine for Spinal Anaesthesia in Below Umbilical Surgeries |
|
Scientific Title of Study
|
Effect of adding fentanyl vs dexmedetomidine in subarachnoid block characteristics with low dose isobaric levobupivacaine 0.5% in below umbilical surgeries A Randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishika garg |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Anaesthesia Rohilkhand Medical College and Hospital
Pilibhit bypass road Bareilly Bareilly UTTAR PRADESH
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7065525250 |
| Fax |
|
| Email |
Ishikagarg.09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarfraj Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Anaesthesia Rohilkhand Medical College and Hospital
Pilibhit bypass road Bareilly Bareilly UTTAR PRADESH
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9027347787 |
| Fax |
|
| Email |
sarfaraz_ahm2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarfraj Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Anaesthesia Rohilkhand Medical College and Hospital
Pilibhit bypass road Bareilly Bareilly UTTAR PRADESH
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9027347787 |
| Fax |
|
| Email |
sarfaraz_ahm2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital
Pilibhit bypass road Bareilly UTTAR PRADESH 243006 India |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Anaesthesia Rohilkhand Medical College and Hospital
Pilibhit bypass road, Bareilly Bareilly UTTAR PRADESH 243006 India
|
| 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 sarfraj ahmad |
Rohilkhand medical college and hospital |
Department
of anesthesiology
Rohilkhand Medical
College and Hospital
Philibhit bypass road
Bareilly
Bareilly
UTTAR PRADESH |
9027347787
sarfaraz_ahm2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee rmch bareilly up |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA grade 1 2 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
As soon as the patient enters the operation theatre after attaching the monitor Following strict aseptic protocols spinal anesthesia was administered by injecting the drug into the L3-L4 or L4-L5 1ml of 0.5% isobaric levobupivacaine with Intrathecal Dexmedetomidine 5mcg intervertebral space using a 25G Quincke needle while the patient was seated afterward the patient was positioned laterally or supine for surgery During the surgery the patients pulse rate Systolic and Diastolic blood pressure will be observed Blood pressure specifically Mean Arterial Pressure was monitored every 3 minutes for the first 30 minutes and then every 5 minutes until the surgery ended |
| Intervention |
Fentanyl |
As soon as the patient enters the operation theatre after attaching the monitor Following strict aseptic protocols spinal anesthesia was administered by injecting the drug into the L3-L4 or L4-L5 1ml of 0.5% isobaric levobupivacaine with Intrathecal fentanyl 25 mcg intervertebral space using a 25G Quincke needle while the patient was seated afterward the patient was positioned laterally or supine for surgery During the surgery the patients pulse rate Systolic and Diastolic blood pressure will be observed Blood pressure specifically Mean Arterial Pressure was monitored every 3 minutes for the first 30 minutes and then every 5 minutes until the surgery ended |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I or II
Elective infraumbilical surgeries under spinal anesthesia
Written informed consent obtained
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Known allergy to study drugs
Patients using alpha 2adrenergic receptors antagonists calcium channel blockers angiotensin converting enzyme inhibitor
Local infection at the injection site
Sepsis and Septic shock
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Dexmedetomidine and fentanyl in terms of
1 Hemodynamic parameters heart rate HR systolic blood pressure SBP diastolic blood pressure DBP mean arterial
pressure MAP
2 Oxygen saturation SpO2 |
During intraoperative period the
Heart Rate Blood Pressure SpO2
Monitored
Every 3 Minutes for 30 Minutes
Then Every 5 Minutes for 1 hours
than every 15 minutes for next
hours Until Surgery Completed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time from spinal injection to first request for rescue analgesia
Adverse effects such as bradycardia low blood pressure nausea vomiting itching drowsiness and respiratory depression were observed and treated as needed
|
Time from spinal injection to first request for rescue analgesia |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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 a preferred technique for infraumbilical surgeries due to rapid onset dense neural blockade and effective postoperative analgesia However using low dose local anaesthetic agents may reduce side effects but can limit block duration and quality. The addition of intrathecal adjuvants such as fentanyl and dexmedetomidine has been shown to enhance the quality and duration of spinal block .This randomized controlled double-blind study aims to compare the effects of adding fentanyl versus dexmedetomidine to low-dose (0.5%) isobaric levobupivacaine in patients undergoing elective infra-umbilical surgeries under spinal anaesthesia. A total of 80 adult patients ASA I–II aged 18–60 years will be randomly allocated into two equal groups. Group D will receive 1.5 mL of 0.5% isobaric levobupivacaine with 5 µg dexmedetomidine, and Group F will receive 1.5 mL of 0.5% isobaric levobupivacaine with 25 µg fentanyl intrathecally. Block characteristics onset and duration of sensory and motor blockade duration of postoperative analgesia and hemodynamic changes will be recorded. Adverse effects such as bradycardia hypotension nausea vomiting pruritus and drowsiness will also be monitored. The expected outcome is to determine which adjuvant fentanyl or dexmedetomidine provides better spinal block characteristics prolonged postoperative analgesia and stable hemodynamic profile when combined with low dose isobaric levobupivacaine for below umbilical surgeries. |