| CTRI Number |
CTRI/2025/06/089294 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Medications (Dexmedetomidine and Remifentanil) to Safely Lower Blood Pressure During Spine Surgery in People with managed High Blood Pressure |
|
Scientific Title of Study
|
Comparative Study between dexmedetomidine infusion and remifentanil infusion for hypotensive anesthesia in controlled hypertensive patients undergoing spine surgeries |
| 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.Kamma Manisha chowdary |
| Designation |
PG resident |
| Affiliation |
IMS&SUM hospital |
| Address |
Department of anesthesiology, IMS&SUM hospital, Siksha O Anusandhan University, Bhubaneswar, Khorda, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9441813236 |
| Fax |
|
| Email |
manishachowdary6699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swarna banerjee |
| Designation |
Professor |
| Affiliation |
IMS&SUM hospital |
| Address |
Department of anesthesiology, IMS&SUM hospital, Siksha O Anusandhan University, Bhubaneswar, Khorda, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9437341397 |
| Fax |
|
| Email |
dr.swarnabanerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamma Manisha chowdary |
| Designation |
PG Resident |
| Affiliation |
IMS&SUM hospital |
| Address |
Department of anesthesiology, IMS&SUM hospital, Siksha O Anusandhan University, Bhubaneswar, Khorda, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9441813236 |
| Fax |
|
| Email |
manishachowdary6699@gmail.comm |
|
|
Source of Monetary or Material Support
|
| IMS&SUM hospital, Siksha O Anusandhan University, Bhubaneswar, Khorda, Orissa ,India ,751003 |
|
|
Primary Sponsor
|
| Name |
IMS&SUM hospital |
| Address |
Kalinga Nagar, Bhubaneswar, Odisha, 751003 |
| Type of Sponsor |
Private 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 |
| DrKamma Manisha chowdary |
IMS&SUM hospital |
Department of anesthesiology, neurosurgery OT,IMS&SUM hospital, Siksha O Anusandhan University, Kalinga Nagar, Bhubaneswar, Odisha, India
Khordha
ORISSA |
9441813236
manishachowdary6699@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IMS&SUM HOSPITAL |
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 in group Dex will be administered a loading dose of 0.3-1mcg/kg for 10min followed by continuous infusion of dexmedetomidine @ 0.3-0.7mcg/kg/hr till the end of surgery |
| Comparator Agent |
REMIFENTANIL |
Patients in group Rem will be receiving remifentanil loading dose of 1mcg/kg for 2min followed by infusion @ 0.1-1mcg/kg/hr till the end of surgery
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for elective spine surgeries with controlled hypertension
2.Age group of 20 to 65 years
3.Patients belonging to ASA class-2
4.Patients who have given informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Patient not giving consent
2.known allergy to either drug
3.Opioid dependence
4.Any coagulation disorders
5.Patient taking anticoagulant drugs
6.Re-operative surgery
7.Uncontrolled hypertension & diabetes
8.Patients with significant cardiovascular or respiratory diseases
9.Patients with neurological or psychiatric disorders affecting pain perception reporting
|
|
|
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 |
| To compare the efficacy of dexmedetomidine versus remifentanil in achieving controlled hypotension during spine surgeries |
Baseline, 10 minutes, 30 minutes, 60 minutes, at extubation, 30 minutes after extubation, 60 minutes after extubation, 90 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate intraoperative blood loss, hemodynamic stability, Postoperative pain scores(VAS), duration of sedation and adverse effects associated with each agent |
Baseline, 10 minutes, 30 minutes, 60 minutes, at extubation, 30 minutes after extubation, 60 minutes after extubation, 90 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2025 |
| 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 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
|
Controlled hypotension is crucial in spine surgeries to minimize blood loss and improve the surgical field, yet managing it in controlled hypertensive patients presents unique challenges. Remifentanil, an ultra-short-acting opioid, allows for rapid blood pressure control.However, it can cause bradycardia, respiratory depression, and lacks postoperative analgesia. Rebound hypertension is also a concern. Dexmedetomidine, a selective alpha-2 agonist, offers sedation, analgesia-sparing effects, and hemodynamic stability by reducing sympathetic outflow.Studies suggest it can achieve controlled hypotension with potentially fewer bradycardic episodes and smoother recovery.However, its slower onset is a consideration. While both agents are used for controlled hypotension, direct comparisons in controlled hypertensive patients undergoing spine surgery are limited. Hypertensive individuals may exhibit different responses due to altered hemodynamics . Understanding the optimal agent regarding intraoperative stability, postoperative outcomes, and side effects in this specific population is vital. This thesis aims to compare dexmedetomidine and remifentanil infusions for hypotensive anesthesia in controlled hypertensive patients undergoing spine surgeries, contributing evidence for informed clinical decision-making in this challenging context |