| CTRI Number |
CTRI/2024/03/064440 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of two medicines added to the regular medicine in producing numbness of the lower half of the body for surgeries |
|
Scientific Title of Study
|
Intrathecal dexmedetomidine versus nalbuphine as adjuvant to levobupivacaine among patients undergoing infraumblical surgeries in tertiary care hospital |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sateesh kumar J |
| Designation |
Post graduate |
| Affiliation |
Sree balaji medical College and hospital |
| Address |
Department of anesthesia ,
3rd floor ,
Sree balaji medical College hospital, CLC works road , chromepet, chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
8838217757 |
| Fax |
|
| Email |
sathish6228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidhya N |
| Designation |
Professor |
| Affiliation |
Sree balaji medical College and hospital |
| Address |
Department of anesthesiology, Sree balaji medical College and hospital,CLC works road, chromepet
Chennai
TAMIL NADU
600044
India |
| Phone |
9597836540 |
| Fax |
|
| Email |
drvidhya.subramanian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidhya N |
| Designation |
Professor |
| Affiliation |
Sree balaji medical College and hospital |
| Address |
Department of anesthesiology, Sree balaji medical College and hospital,CLC works road, chromepet
Chennai
TAMIL NADU
600044
India |
| Phone |
9597836540 |
| Fax |
|
| Email |
drvidhya.subramanian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree balaji medical College and hospital, CLC works road , chromepet, chennai-600044 |
|
|
Primary Sponsor
|
| Name |
Sree Balaji medical College and hospital |
| Address |
Sree balaji medical College and hospital, CLC works road, chromepet, Chennai -600044 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sateesh Kumar J |
Sree balaji medical College and hospital |
Fourth floor operation theatre, department of anesthesia, sree balaji medical College and hospital, CLC works road, chromepet, chennai -600044
Chennai
TAMIL NADU |
8838217757
sathish6228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree balaji medical College and hospital, Institutional human ethics committee |
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 |
Dexmedetomidine |
Patients will be administered dexmedetomidine 5mcg along with 0.5% hyperbaric levobupivacaine for spinal anaesthesia . Route- intra- thecal, frequency of administration - single dose administered before surgery |
| Comparator Agent |
Nalbuphine |
Patient will be administered nalbuphine 0.5mg along with 0.5% hyperbaric levobupivacaine in spinal anaesthesia . Route of administration - intra-thecal, frequency - single dose administered before surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All elective infraumblical surgeries
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
History of allergy to study drugs
Local site infection
History of spinal surgeries, spinal deformities
Coagulopathy
Dysrhythmia
BMI more than 35
Height less than 150 cm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
onset of sensory and motor block ,
Duration of sensory and motor block |
1. Time of administration of drug
2. Onset of sensory block
3. Onset of motor block
4. Time of regression of sensory block to T10
5. Time of recovery of motor block to modified bromage scale 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Time of administration of first dose of rescue analgesia |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
28/03/2024 |
| 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="3"
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
|
Introduction: Adjuvants to local anaesthetics have synergistic action and intensify sensory block without increasing sympathetic block, reduced local anaesthetic drug dose, better hemodynamic stability with lesser side effects. Levobupivacaine is a local anaesthetic amide which can produce better sensory and motor block with good hemodynamic profile and lesser cardio toxicity than bupivacaine. Dexmedetomidine an α2-adrenergic agonist and Nalbuphine, a synthetically prepared opioid are two drugs which can be used as adjuvants with local anaesthetic By combining these adjuvants to local anaesthetic drugs, one can lower the dose of local anaesthetic agent and maintain analgesic efficacy while reducing the incidence and severity of side effects. Dexmedetomidine mediates its analgesic effects via spinal α2 receptors by depressing the release of C-fiber neurotransmitters and by hyperpolarization of postsynaptic dorsal horn neurons Until now, there is no specific recommended dose of dexmedetomidine for intrathecal administration. Dose can be varied from 3 to 15 µg as an adjuvant to local anaesthetic in spinal anesthesia. Nalbuphine is a highly lipid-soluble opioid analgesic and mixed synthetic agonist-antagonist, which attenuates the μ-opioid effects and enhances the κ-opioid effects to provide reasonably potent analgesia of visceral nociception Intrathecal nalbuphine prolongs the duration of postoperative analgesia when used as an adjunct, and prolongs early postoperative analgesia without increasing the risk of side-effects. Its peak analgesic effects with minimal side effects at doses ranges from 0.4 to 1.6 mg . Methodology: In this study , Patient will be administered spinal anaesthesia with 0.5% hyperbaric Levobupivacaine 2.8ml with DEXMEDETOMIDINE 5mcg or NALBUPHINE 0.5mg as an adjuvant ( total = 3ml ) The purpose of this study is to compare the efficacy of intrathecal DEXMEDETOMIDINE and NALBUPHINE as an adjuvant to 0.5% hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries under sub arachnoid block by observing the time of onset of sensory and motor block , time taken for highest sensory block , time taken for sensory regression, time of regression to level T10 . The secondary objectives are time of rescue analgesic and intraoperative hemodynamic stability. |