| CTRI Number |
CTRI/2022/05/042376 [Registered on: 04/05/2022] Trial Registered Prospectively |
| Last Modified On: |
21/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial to assess the effect of blood pressure lowering drug (Dexmedetomidine) to control blood loss during spine surgery |
|
Scientific Title of Study
|
Effect Of Dexmedetomidine Infusion On Intraoperative Hemodynamics And Anesthetic
Requirements In Patients Undergoing Elective Spine Surgery: A Prospective Randomized Control
Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJALI SATHISH |
| Designation |
RESIDENT |
| Affiliation |
PADMASREE D Y PATIL MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANESTHESIA
PADMASREE D Y PATIL MEDICAL COLLEGE
NERUL
NAVI MUMBAI
Thane
MAHARASHTRA
400706
India |
| Phone |
9495461746 |
| Fax |
|
| Email |
anjalisathish18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VARSHA VYAS |
| Designation |
PROFESSOR |
| Affiliation |
PADMASREE D Y PATIL MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANESTHESIA
PADMASREE D Y PATIL MEDICAL COLLEGE
NERUL
NAVI MUMBAI
Thane
MAHARASHTRA
400706
India |
| Phone |
9819583232 |
| Fax |
|
| Email |
varsha.vyas011@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
ANJALI SATHISH |
| Designation |
RESIDENT |
| Affiliation |
PADMASREE D Y PATIL MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANESTHESIA
PADMASREE D Y PATIL MEDICAL COLLEGE
NERUL
NAVI MUMBAI
MAHARASHTRA
400706
India |
| Phone |
9495461746 |
| Fax |
|
| Email |
anjalisathish18@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y. Patil School of Medicine |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| ANJALI SATHISH |
PADMASREE D Y PATIL MEDICAL COLLEGE |
DEPARTMENT OF ANESTHESIA
D Y PATIL SCHOOL OF MEDICINE
NERUL
NAVI MUMBAI
Thane
MAHARASHTRA |
9495461746
anjalisathish18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
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 |
Dexmedetomidine - GROUP A |
LOADING DOSE - 1 MCG/KG/HOUR IV FOR 10 MINUTES
AND
MAINTENANCE DOSE - 0.2 - 0.7 MCG/KG/HOUR CONTINOUS |
| Comparator Agent |
Dexmedetomidine - GROUP B |
MAINTENANCE DOSE ONLY - 0.2 - 0.7 MCG/KG/HOUR CONTINOUS INFUSION |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients giving consent
Elective spinal surgeries only
Patients aged >18 years & < 65 years
Patients of either sex
ASA Grade I & II |
|
| ExclusionCriteria |
| Details |
PREGNANT PATIENTS
PATIENTS SUFFERING FROM HYPERTENSION
UNCONTROLLED DIABETES MELLITUS
MORBID OBESITY
COPD
SEVERE RENAL, HEPATIC, CARDIAC DYSFUNCTION
EMERGENCY SPINE SURGERY
HISTORY OF DRUG ABUSE |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
HYPOTENSION
BLOOD LOSS
ANALGESIA USE |
HYPOTENSION - EVERY 30 MINUTES
BLOOD LOSS - EVERY 30 MINUTES
ANALGESIA USE - EVERY 30 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANALGESIA REQUIREMENT |
ANALGESIA USE - EVERY 1 HOUR |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
31/05/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dexmedetomidine is a highly selective
alpha-2-agonist that has been widely used in anesthetic practice as an adjuvant
because of its desirable properties . It has anti-nociceptive , analgesic
,opioid sparing and sedative properties without respiratory depression.it
decreases sympathetic tone thereby reducing heart rate and blood pressure. It
also increases the stress response to surgery.the dose of dexmedetomidine often
quoted in the literature is a bolus of 1 mcg/kg/hr over 10 minute followed by
infusion of 0.2-0.7 mcg/kg/hr,but this dose frequently results in brady cardia
and hypotension
The
primary aim of the study is to evaluate the effect of dexmedetomidine infusion
on intraoperative blood loss , haemodynamic changes and anaesthetic
requirements in the patients undergoing elective spine surgery The secondary
aim is to study its effect on intraoperative anesthetic and analgesic requirements
during the surgery
|