| CTRI Number |
CTRI/2024/11/076475 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To find the optimal dose of Dexmedetomidine as an adjuvant for relieving post operative pain when used in Spinal Anesthesia |
|
Scientific Title of Study
|
Efficacy of Different Doses of Dexmedetomidine Intrathecally as an Adjuvant to Low Dose Hyperbaric Levobupivacaine in Urological Procedures: A Comparative Study to Determine the Optimal Dose |
| 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 Lakshmi Mahajan |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9855286122 |
| Fax |
|
| Email |
drlakshmimahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Babrah |
| Designation |
Assistant Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9023448624 |
| Fax |
|
| Email |
docharpreet21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jobanjeet Kaur Hundal |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9888403544 |
| Fax |
|
| Email |
drjobanhundal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research,Mehta Road, vallah,Amritsar. 143001 |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, 143001 |
| 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 |
| Dr Ruchi Gupta |
Sri Guru Ram Das Institute of Medical Sciences and Research |
OT-1 and 2, main OT, Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar,143001
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical 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 |
| Comparator Agent |
Intrathecal Dexmedetomidine |
Intrathecally Dexmedetomidine will be given to
Group A - dexmedetomidine 5mcg.
Group B- dexmedetomidine 7.5 mcg.
Group C- dexmedetomidine 10 mcg. |
| Intervention |
Spinal Anaesthesia |
Hyperbaric 2.2ml Levobupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Physical status I - II
2.Patients undergoing Transurethral resection of prostate, Ureteroscopic lithotripsy,Cystoscopy, Other urological procedures under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to study drugs.
2.History of coagulopathy
3.Skin infection at spinal site
4.Spine deformity
5.Major Co-morbidities (hepatic, renal and cardiovascular)
6.Pregnant female
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of post operative analgesia by three different doses of dexmedetomidine when used as adjuvant to low dose hyperbaric levobupivacaine in spinal anaesthesia using VAS Score |
from completion of surgery till 12 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To measure time to first request and total number of rescue analgesia postsurgery in first 12 hours in each group.
2.To investigate the incidence of adverse effects.
- Bradycardia
- Hypotension
- Post operative nausea /vomiting
- Respiratory depression
- sedation
|
from completion of surgery till 12 hours postoperative |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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="1"
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
|
Introduction: Effective perioperative pain management in urological procedures is
imperative for patient comfort and postoperative recovery. This study seeks to address
this need by investigating the efficacy and safety of varying doses of intrathecal
dexmedetomidine as an adjuvant to low-dose hyperbaric levobupivacaine for
enhancing postoperative analgesia while maintaining hemodynamic stability.
Aims & Objectives: The primary aim of this prospective, randomized, double-blind
study is to determine the optimal dose of dexmedetomidine which prolongs
postoperative analgesia, by comparing three varying doses. We aim to assess their
respective abilities reduce the need for rescue analgesia, and minimize adverse effects
in patients undergoing spinal anaesthesia for urological procedures.
Methodology: 90 patients, aged 18-75y, will be randomized into three groups of 30
patients each. Each will receive hyperbaric levobupivacaine 2.2 ml with 5 µg ,7.5 µg
and 10 µg of dexmedetomidine in group A, B and C respectively, diluted to 2.4 ml
with 0.9 ml normal saline. After comprehensive pre-anaesthetic evaluation,
standardized drug preparation, and a meticulous anaesthesia technique, continuous
monitoring of vital signs, onset of sensory and motor block, and occurrence of adverse
events will be noted intraoperatively. Postoperatively, the duration of analgesia,
frequency of rescue analgesia, and incidence of side effects will be recorded.
Significance: This study has potential to contribute to the development of tailored
perioperative pain management protocols. By elucidating the most effective dose of
dexmedetomidine, this research may lead to reduced opioid consumption, improved
patient satisfaction, and enhanced postoperative recovery. Furthermore, the findings
may offer valuable insights into optimizing pain control strategies for geriatric patients
with multiple comorbidities undergoing urological surgeries under spinal anaesthesia. |