| CTRI Number |
CTRI/2025/06/089299 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of fentanyl and dexmedetomidine as adjuvants with intrathecal hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries |
|
Scientific Title of Study
|
Comparsion of effects of adjuvants fentanyl and dexmedetomidine with intrathecal hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries: a randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADVAIT RAMESH PILLAI |
| Designation |
postgraduate trainee |
| Affiliation |
Jawaharlal Nehru Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Institute of Medical Sciences, Imphal
Imphal East,
Manipur- 795005
India
Imphal East
MANIPUR
795005
India |
| Phone |
6282276352 |
| Fax |
|
| Email |
advaitrpillai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KEISHAM UPENDRA SINGH |
| Designation |
Professor, HOD |
| Affiliation |
Jawaharlal Nehru Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Institute of Medical Sciences, Imphal
Imphal East,
Manipur- 795005
India
Imphal East
MANIPUR
795005
India |
| Phone |
9436039203 |
| Fax |
|
| Email |
drupendrakeisham@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KEISHAM UPENDRA SINGH |
| Designation |
Professor, HOD |
| Affiliation |
Jawaharlal Nehru Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Institute of Medical Sciences, Imphal
Imphal East,
Manipur- 795005
India
Imphal East
MANIPUR
795005
India |
| Phone |
9436039203 |
| Fax |
|
| Email |
drupendrakeisham@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Jawaharlal Nehru Institute of Medical Sciences, Imphal East, 795005 India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Institute of Medical Sciences, Imphal East 795005 |
| Type of Sponsor |
Government 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 ADVAIT RAMESH PILLAI |
Jawaharlal Nehru Institute of Medical Sciences, Imphal |
Operation Theatre Complex
Jawaharlal Nehru Institute of Medical Sciences, Imphal East 795005
Imphal East
MANIPUR |
6282276352
advaitrpillai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JNIMS, Imphal |
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 |
fentanyl or dexmeditomedine as adjuvants for hyperbaric levobupivacaine |
Study population is divided into 3 groups A,B and C.
Group A will receive 14mg hyperbaric levobupivacaine along with 10mcg fentanyl intrathecally once before the surgery.
Group B will receive 14mg hyperbaric levobupivacaine along with 5mcg dexmeditomedine intrathecally once before the surgery. |
| Comparator Agent |
Normal saline as a control with hyperbaric levobupivacaine |
Group C will receive 14mg hyperbaric levobupivacaine along with 0.2ml normal saline intrathecally once before the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 - 60 years undergoing infraumbilical surgeries
2. Patients who are categorised under ASA I and II
3. Patients who have signed a written informed consent form
|
|
| ExclusionCriteria |
| Details |
Patients refusal
1. Pregnant women
2. Patients with spine deformities, local infection near the injection site
3. Patients with history of allergy to study drugs
4. Patients with abnormal coagulation profile
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the onset and duration of sensory and motor block of intrathecal hyperbaric levobupivacaine alone, hyperbaric levobupivacaine with fentanyl, and hyperbaric levobupivacaine with dexmedetomidine |
The level of sensory block will be assessed by pin prick method every minute after drug administration till 15 minutes from start, then every 15 minutes till the completion of surgery.
Motor block will be assessed by Modified Bromage Scale every minute till Modified Bromage grade 3 is achieved.
Then motor block assessed every hourly for 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic effects. Heart rate, blood pressure, oxygen saturation |
baseline, then every 5 minutes after administration of drug till the surgery ends |
| Total number of rescue analgesia required |
till 12 hours after completion of surgery |
| Analgesic profile |
1. Visual Analog Scale at the end of surgery
2. Visual Analog Scale when patient asks for 1st rescue analgesic dose |
|
|
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)
|
07/07/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study will be prospective, randomised and double blinded. We will compare the effect of fentanyl vs dexmeditomedine as adjuvants to hyperbaric levobupivacaine on patients undergoing infraumbilical surgery under spinal anaesthesia. It is aimed to compare the onset and duration of sensory and motor block , hemodynamic changes, duration of analgesia, need of rescue analgesia and post-operative analgesic profile. A total number of 93 patients who fall under ASA category I and II will be recruited. They will be randomly allocated into 3 groups containing 32 each designated as Group A, B, C. Group A constitutes patients receiving 3ml drug mix containing 2.8ml (14mg) of Hyperbaric Levobupivacaine with 0.2ml (10mcg) of fentanyl. Group B patients will receive 3ml drug mix containing 2.8ml (14mg) of Hyperbaric Levobupivacaine with 0.2ml (0.5mcg) of dexmeditomedine (0.5ml=50mcg, diluted to 2ml by addition of 1.5ml NS so that each 0.1ml contains 2.5 mcg of dexmeditomedine). Group C 3ml drug mix containing 2.8ml (14mg) of Hyperbaric Levobupivacaine with 0.2ml of Normal Saline. Patients will be assessed for the impact of drugs on the parameter mentioned above and the data will be recorded. The data will be then analysed and interpreted by appropriate statistical method. |