| CTRI Number |
CTRI/2023/08/056887 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of dexmedetomidine and fentanyl as adjuncts to intrathecal 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing total abdominal hysterectomy |
|
Scientific Title of Study
|
Comparison of Fentanyl and Dexmedetomidine as adjuvants to hyperbaric levobupivacaine (0.5%) in elective total abdominal hysterectomy |
| 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 SUBHADEEP GUHA |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8617383944 |
| Fax |
|
| Email |
pointersubho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharati |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anaesthesiology RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9599277395 |
| Fax |
|
| Email |
bharati.bediya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Suman |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anaesthesiology RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
7079893536 |
| Fax |
|
| Email |
saurabh31.7.dmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Bariatu, Ranchi |
| 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 SUBHADEEP GUHA |
Rajendra Institute of Medical Sciences |
PAC room, Department of Anaesthesia
Ranchi
JHARKHAND |
8617383944
pointersubho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Rajendra Institute of Medical Sciences, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levobupivacaine with dexmedetomidine in spinal anaesthesia |
3ml 0.5% hyperbaric levobupivacaine and 10mcg dexmedetomidine (0.5ml) administered via intrathecal route, single dose. Effects monitored for 12hours |
| Intervention |
Levobupivacaine with fentanyl in spinal anaesthesia |
3ml 0.5% hyperbaric levobupivacaine and 25 mcg fentanyl(0.5ml) administered via intrathecal route, single dose. Effects monitored for 12hours |
| Comparator Agent |
Levobupivacaine with sterile normal saline in spinal anaesthesia |
3ml 0.5% hyperbaric levobupivacaine and 0.5ml sterile normal saline administered via intrathecal route, single dose. Effects monitored for 12hours |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patient’s consent
Patients posted for elective total abdominal hysterectomy at Rajendra Institute of Medical Sciences
ASA physical status I & II |
|
| ExclusionCriteria |
| Details |
Patient’s with contradictions to spinal anaesthesia, neurological diseases, allergy or intolerance to local anaesthetic agents or other agents used for the study.
Presence of co-morbidities like severe anaemia, uncontrolled diabetes mellitus, asthma, uncontrolled hypertension, severe cardiac disease
Patient’s belonging to ASA III and above |
|
|
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 |
1. Comparison of sensory block achieved at T10 level after induction.
2. Duration of sensory block
3. Onset of motor block
4. Duration of motor block |
1. From the time of induction to time taken to reach T10 dermatome.
2. From the time of induction till patient feels the sensation at S1 dermatome.
3. From the time of induction till patient attains modified Bromage scale grade 1 motor blockage.
4. From the time of induction till patient attended complete motor recovery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To calculate the total duration of analgesia & consumption of rescue analgesia.
2. To study the hemodynamic changes like HR, SBP, DBP, MAP, RR side effects & complications, if any. |
1. Total rescue analgesia forfirst 24hours.
2. Hemodynamic changes every 3 mins till first 15mins, every 5 mins for 1hr, every hourly for first 6 hours, then 6 hourly for first 24hours.
3. Complications if any for first 24hours. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
31/08/2023 |
| 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 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
|
Neuraxial blockade in the form of spinal anaesthesia has been a very popular choice of anaesthesia for a multitude of surgeries, extending from caesarean section to lower limb surgeries. Many drugs starting from opioids, magnesium sulphate, vasopressors and alfa-2 adrenergic agomists like dexmedetomidine and clonidine have been tried as an adjunct to local anaesthestic to manage this problem of post operative pain. Levobupivacaine is a member of the amino amide class of local anaesthetics. The mechanism of its action is by blockade of sodium ion channels through the nerve membrane. It is preferred over bupivacaine because of its lower incidence of intraoperative hypotension. Fentanyl is a synthetic short acting opioid which acts centrally and thus widely used for pain control. Intrathecal fentanyl is usually used as an adjunct to local anaesthetics to increase anaesthesia and analgesia by its synergistic effects. Dexmedetomidine, on the other hand, is a new selective alpha 2 agonist, which has not only analgesic and sedative properties but also has sympatholytic activity. In this study, our aim is to compare the efficacy of fentanyl and dexmedetomidine added to intrathecal 0.5% hyperbaric levobupivacaine in patients undergoing total abdominal hysterectomy. |