| CTRI Number |
CTRI/2022/04/042101 [Registered on: 22/04/2022] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| 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
|
A study to see whether a medicine given as a tablet is as effective in reducing the blood pressure compared to another medicine given as injection in patients who need back surgery. Both medicines reduce blood pressure and may reduce blood loss. |
|
Scientific Title of Study
|
Randomized controlled study comparing the efficacy of oral Clonidine and intravenous Dexmedetomidine in maintaining the hemodynamic stability in patients undergoing major spine surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narmatha K |
| Designation |
DNB Candidate |
| Affiliation |
Sri Narayani Hospital and Research Centre |
| Address |
Dept of Anesthesia
Sri Narayani Hospital & Research Centre
Thirumalaikodi
Vellore
Vellore
TAMIL NADU
632055
India |
| Phone |
9787733388 |
| Fax |
|
| Email |
narmatha.shanthi.k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishnan B S |
| Designation |
HOD |
| Affiliation |
Sri Narayani Hospital and Research Centre |
| Address |
Dept of Anesthesia
Sri Narayani Hospital & Research Centre
Thirumalaikodi
Vellore
Vellore
TAMIL NADU
632055
India |
| Phone |
6380546634 |
| Fax |
|
| Email |
b_s_krishnan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnan B S |
| Designation |
HOD |
| Affiliation |
Sri Narayani Hospital and Research Centre |
| Address |
Dept. of Anesthesia
Sri Narayani Hospital & Research Centre
Thirumalaikodi
Vellore
Vellore
TAMIL NADU
632055
India |
| Phone |
6380546634 |
| Fax |
|
| Email |
b_s_krishnan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Narayani Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| 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 |
| Krishnan B S |
Sri Narayani Hospital and Research Centre |
Department of Anesthesiology
Sri Narayani Hospital and Research Centre
Thirumalaikodi
Vellore
Vellore
TAMIL NADU |
6380546634
b_s_krishnan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI NARAYANI HOSPITAL AND RESEARCH CENTRE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Dexmedetomidine 0.5microgram/kg/hour after turning the patient prone for surgery. |
Patients in this arm receive Tab Diazepam 10 mg as a placebo for blinding purposes and receive the infusion of Dexmedetomidine intraoperatively |
| Comparator Agent |
Oral Clonidine 200 micrograms 2 hrs prior to surgery |
Intraoperatively these patients will receive an infusion of normal saline for blinding purposes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 1 and 2
2. 2 or more level spine instrumentation |
|
| ExclusionCriteria |
| Details |
1. ASA physical status 3 and 4
2. Patients on Chronic Beta blocker therapy
3. Patients with uncontrolled blood pressure
4. Patients with renal or liver disease
5. Patients on ACE inhibitors/ ARBs |
|
|
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 |
| Measurement of Systolic, diastolic and mean blood pressures during surgery. Heart rate, number of episodes of hypotension and hypertension will also be recorded |
Recordings will be baseline before intubation, after intubation, after proning the patient and every 15 minutes till end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare intraoperative analgesic requirements, blood loss and recovery time from anesthesia |
Total dose of fentanyl and propofol needed during surgery and blood loss at the end of surgery will be calculated. All measurements will be completed by the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2022 |
| Date of Study Completion (India) |
01/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a double blind randomized clinical trial being conducted by a postgraduate on patients undergoing major spine surgery. The hemodynamic stablity of these patients is being assessed after receiving either oral Clonidine or Intravenous Dexmedetomidine during surgery.Also the blood loss in these patients is being compared. |