| CTRI Number |
CTRI/2013/03/003513 [Registered on: 25/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
22/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effects of two drugs, Dexmedetomidine and Fentanyl, on the blood pressure and heart rate in patients with high blood pressure, undergoing major surgery |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine with Fentanyl for maintenance of intra-operative hemodynamics in hypertensive patients undergoing major surgery - A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanchan V Bilgi |
| Designation |
Post-graduate student |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and Critical Care
JIPMER
Dhanvantri Nagar
Puducherry 605006
Department of Anaesthesiology and Critical Care
JIPMER
Dhanvantri Nagar
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8526617221 |
| Fax |
|
| Email |
kanchanbilgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudevan A |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and Critical Care
JIPMER
Dhanvantri Nagar
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894444102 |
| Fax |
|
| Email |
jipmervasu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan V Bilgi |
| Designation |
Post-graduate student |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and Critical Care
JIPMER
Dhanvantri Nagar
Puducherry 605006
Department of Anaesthesiology and Critical Care
JIPMER
Dhanvantri Nagar
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8526617221 |
| Fax |
|
| Email |
kanchanbilgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER
Dhanvantri Nagar
Puducherry 605006 |
| 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 |
| Kanchan V Bilgi |
JIPMER Hospital |
JIPMER Hospital
Operation theatres of Obstetrics Gynaecology and General Surgery
Department of Anaesthesiology
Dhanvatri Nagar
Puducherry
Pondicherry
PONDICHERRY |
8526617221
kanchanbilgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertensive
American Society of Anesthesiologists (ASA) 2 physical status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine (selective alpha-2 agonist) |
Loaded as a 2mcg/ml solution in 50ml NS. Loading dose 1mcg/kg infusion given over 10 minutes intravenously. Changed over to maintenance dose of 0.5mcg/kg/hr infusion which is stopped at the end of surgery. (Approximate duration less than 4hrs) |
| Comparator Agent |
Fentanyl (opioid) |
Loaded as a 2mcg/ml solution in 50ml NS. Loading dose 1mcg/kg infusion given over 10mins intravenously. Changed over to maintenance dose 0.5mcg/kg/hr infusion which is stopped at the end of surgery. (Approximate duration less than 4hrs) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Hypertensive patients under American Society of Anesthesiologists (ASA) Physical status 2 posted for major surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Systolic BP> 160mmHg, Diastolic BP>100mmHg
2. H/o ischemic heart disease
3. H/o cerebral vascular disease
4. Impaired renal function tests
4. Impaired liver function tests
5. Laparoscopic procedure
6. Pregnant and suspected full-stomach patients
7. Anticipated difficult airway
8. Surgery with expected significant blood loss (>25%of blood volume) and fluid shifts |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl |
To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Opioid consumption
|
Intra operative
|
| Time to recover from anesthesia (eye opening to verbal call) |
End operative |
| Time to first analgesic request |
Post operative |
|
|
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)
|
15/03/2012 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertensive patients are known to have labile hemodynamics in the intra operative period. Post operative complications like myocardial infractions, arrhythmia, congestive cardiac failure, stroke and renal failure are more likely in the presence of intra operative hemodynamic instability.
Opioids like Fentanyl and Morphine are used extensively, in view of their established sedative and analgesic properties. Their significant side effects include respiratory depression, post-operative nausea and vomiting, and urinary retention. In this study, the aim is to compare the effects of Dexmedetomidine, a highly selective Alpha-2 agonist, with those of Fentanyl on intraoperative hemodynamics,, opioid consumption, time to recovery and duration of post operative analgesia.
The study hypothesis is that Dexmedetomidine provides better hemodynamic stability intra operatively, when compared with fentanyl, while avoiding the side effects of opioids.
|