| CTRI Number |
CTRI/2023/04/051598 [Registered on: 13/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| 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 between two drugs as an additive to a local anaesthesia in spinal anaesthesia for taking baby out by surgical method. |
|
Scientific Title of Study
|
COMPARISON BETWEEN INTRATHECAL FENTANYL AND DEXMEDETOMIDINE AS AN ADJUVANT TO HYPERBARIC 0.5% LEVOBUPIVACAINE IN SUBARACHNOID BLOCK FOR CEASAREAN SECTION: A PROSPECTIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santanu Saha |
| Designation |
Junior Resident |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
9477428027 |
| Fax |
|
| Email |
santanusaha19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman Chattopadhyay |
| Designation |
Professor and Head |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
9830234881 |
| Fax |
|
| Email |
sumanc24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasish Bhar |
| Designation |
Associate Professor |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
8617753967 |
| Fax |
|
| Email |
debasish77bhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college funded post graduate thesis project |
|
|
Primary Sponsor
|
| Name |
Office of the Principal, Midnapore Medical College and Hospital |
| Address |
Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur, Pin 721101, west bengal |
| 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 |
| Santanu Saha |
Midnapore Medical College and Hospital. |
Obstetrics Operation Theatre & Postoperative Recovery Room,Matrima Building, Midnapore Town, Paschim Medinipur, Pin 721101
Medinipur
WEST BENGAL |
9477428027
santanusaha19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics , Midnapore Medical College and Hospital.Approval Memo no- MMC/IEC-2022/2761. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal dexmedetomidine as adjuvant to Hyperbaric 0.5% levobupivacaine. |
Intrathecal Dexmedetomidine 5mcg(Prepared in 0.5ml NS)along with 1.8ml of 0.5% hyperbaric levobupivacaine in subarachnoid block for elective ceasarean section. |
| Intervention |
Intrathecal fentanyl as adjuvant to Hyperbaric 0.5% levobupivacaine. |
Intrathecal Fentanyl 25mcg(0.5ml)along with 1.8ml of 0.5% hyperbaric levobupivacaine in subarachnoid block for elective ceasarean section. |
| Comparator Agent |
Intrathecal normal saline with
Hyperbaric 0.5% levobupivacaine. |
Intrathecal Normal saline 0.5ml along with 1.8ml of 0.5% hyperbaric levobupivacaine in subarachnoid block of elective ceasarean section. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade II
2. Age group of 18-30 years
3. Body Mass Index between 18.5 and 24.
4. Gestational age ≥37 weeks
5. Elective lower segment caesarean section under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe cardio-respiratory disease
2. Patients with hepatic & renal disease
3. Patients with neurologic disorder
4. Patients with endocrine disorder
5. Patients with H/O Antepartum Hemorrhage (APH)
5. Subarachnoid block inadequate or failure
6. Conversion to general anesthesia
7. Patients with psychiatric problem
8. Any contraindication for spinal anesthesia
9. Drug allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
We are using equipotent dose of fentanyl and dexmedetomidine and both increases the duration of sensory & motor block. we expect both the groups receiving fentanyl and dexmedetomidine will have a longer duration of sensory & motor block compared to patients receiving
normal saline as adjuvant but among fentanyl and dexmedetomidine which one will provide longer duration of sensory & motor block will be known after cpmpletion of the study. |
September 2022 to February 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of surgery |
from the beginning to end ot surgery |
| to measure Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation, VAS Score, ECG |
baseline
every 2 mins for first 10 mins, then every 5 minutes for next 25 mins then every 10 mins till 90 mins during surgery.
post operatively every 2 hours till 6 hours |
| Apgar score of neonates |
at 1 min and 5 min after delivery |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
28/04/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No Publication Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PROPOSED
TOPIC OF RESEARCH:
Comparison between intrathecal fentanyl and dexmedetomidine as an adjuvant to
hyperbaric 0.5% levobupivacaine in subarachnoid block for caesarean section: A
prospective study.
OBJECTIVE
OF PROPOSED RESEARCH:
To compare the duration of sensory and motor block between fentanyl and
dexmedetomidine when administered intrathecally as adjuvant to 0.5% hyperbaric levobupivacaine
in spinal anaesthesia for elective lower segment caesarean section.
Background of present study: In recent years levobupivacaine, the pure S
(−)-enantiomer of bupivacaine, emerged as a safer alternative for regional
anesthesia than its racemic parent. Recently 0.5% hyperbaric levobupivacaine has
been introduced in clinical practice and widely used as a substitution of 0.5%
hyperbaric bupivacaine in spinal anaesthesia.
To
prolong the duration of sensory and motor block many adjuvants have been
previously added to 0.5% hyperbaric bupivacaine in spinal anaesthesia. Fentanyl
and dexmedetomidine both have been profoundly used as adjuvant with 0.5%
hyperbaric bupivacaine in cesarean section. As there is no published data on
the effect of adjuvants with hyperbaric levobupivacaine we propose to compare
the effects of fentanyl and dexmedetomidine with 0.5% hyperbaric
levobupivacaine in caesarean section.
Methodology: After ethical
clearance and written informed consent, 105 mothers undergoing elective
caesarean section will be randomly allocated into three groups. Group F will received
intrathecal fentanyl 25 mcg (0.5 ml) along with 1.8 ml of 0.5% hyperbaric levobupivacaine,
group D will received intrathecal dexmedetomidine 5 mcg (prepared in 0.5 ml of
normal saline) along with 1.8 ml of 0.5% levobupivacaine and group C will be
given 0.5 ml of normal saline along with same dose of 0.5% of hyperbaric levobupivacaine.
Maximum level of sensory block, time for two segment regression of sensory
block and duration of motor block will be recorded. Post operative analgesia
will be assessed by using visual analogue score (VAS) and patients complaining
of VAS>4 will be given rescue analgesia. Time of first dose of
post-spinal rescue analgesic will be noted.
Expected outcome: As there is no previous published data comparing fentanyl and
dexmedetomidine as adjuvant with 0.5% hyperbaric levobupivacaine, we accept
that there will be no difference regarding the duration of sensory and motor
block in these two groups. |