| CTRI Number |
CTRI/2011/10/002046 [Registered on: 11/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
13/02/2012 |
| 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
|
study the effectiveness of dexmedetomidine, a drug,given before start of surgery by anesthetist, in preventing increase in blood pressure and pulse rate which generally occurs at that time and can result in dangerous arrhythmias and heart attack |
|
Scientific Title of Study
|
DEXMEDETOMIDINE AS AN ADJUNCT TO ANESTHETIC INDUCTION TO ATTENUATE HEMODYNAMIC RESPONSE TO ENDOTRACHEAL INTUBATION IN PATIENTS UNDERGOING SURGICAL PROCEDURES UNDER GENERAL ANESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Meenaxi Sharma |
| Designation |
M.B.B.S, M.D (ANAESTHESIOLOGY) PROFESSOR |
| Affiliation |
swai man singh medical college jaipur |
| Address |
department of anesthesiology, swai man singh medical college and attached hospitals jaipur
jaipur, rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
09784371780 |
| Fax |
|
| Email |
drmeenaxi@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
rishabh kumar |
| Designation |
MD ANAESTHESIOLOGY(resident) |
| Affiliation |
swai man singh medical college jaipur |
| Address |
department of anaesthesiology, swai man singh medical college and attached hospitals
jaipur rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
09694580547 |
| Fax |
|
| Email |
cool_rishu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
rishabh kumar |
| Designation |
MD ANAESTHESIOLOGY(resident) |
| Affiliation |
swai man singh medical college jaipur |
| Address |
department of anesthesiology, swai man singh hospital
jaipur rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
09694580547 |
| Fax |
|
| Email |
cool_rishu@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Swai Maan Singh Medical college and hospital jaipur |
|
|
Primary Sponsor
|
| Name |
Swai Maan singh Medical College and Attached hospital |
| Address |
Swai Maan Singh Medical College and Attached hospital, jaipur |
| Type of Sponsor |
Government 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 |
| Rishabh Kumar |
Swai Maan Singh Medical college And Hospital, JAIPUR |
operation theater number 2, department of anesthesiology, Swai Maan Singh Medical college and hospital , JAIPUR
Jaipur
RAJASTHAN |
09694580547
cool_rishu@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
surgery under general anesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE as premedecation |
Intravenous infusion(4 microgam/ml) for 10 min. total dose 1 microgram/kg. given once |
| Comparator Agent |
Normal saline |
Normal Saline (0.9%) for 10 min intravenous infusion. Dose in ml will be weight(Kg) /4. given once. It will be used as control |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA grade 1 and 2
2.Patients of age group 18 to 55 years of either sex undergoing surgery under general anesthesia
3.Patients willing to give written and informed consent
|
|
| ExclusionCriteria |
| Details |
1.Patients refusal
2.Major organ dysfunction
3.Patients on medications like hypnotics, narcotic analgesics, α2 agonists, calcium channel blockers, β blockers
4.Patients with anticipated difficult intubation
5.Patients intubated after more than 1 attempt or more than 20 seconds
6.Patients with impaired LFT/RFT
7.Patients with ASA grade 3, 4, 5
8.Deaf and dumb patients
9.Patients with respiratory and cardiac disease
10.Patients having known allergy to anesthetic agents used in study
11.Psychiatric patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in systolic, diastolic and mean blood pressure, pulse rate, oxgen saturation compared to baseline at various points before and after intubation compared to baseline |
5 , 10 ,13,14(just after intubation),15,18,20,25 min after start of drug infusioon and baseline parameters |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications like bradycardia , hypotention etc |
intraoperative( time period may vary and immediate post operative till 10 min after extubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Conventional laryngoscopy and endotacheal intubation cause significant changes in hemodynamics of patients i.e. increase in heart rate and blood pressure and precipitate arrhythmias which may lead to ischemia and myocardial infarction. In present study dexmedetomidine will be used in combination with fentanyl to attenuate this response. The aim of study is to study the effect of dexmedetomidine over and above fentanyl in attenuating the hemodynamic response to laryngoscopy and intubation.In this prospective randomized double blind placebo controlled trial 100 patients will be selected and divided into 2 groups of 50 each. Baseline parameters like body weight , pulse rate and blood pressure will be recorded. Inj.glycopyrolate and inj. fentanyl will be given as premedication. Test drug ( dexmedetomidine/ placebo) will be given by infusion in a double blind fashion. Rate of infusion is adjusted according to body weight. Induction of anesthesia is done with inj. propofol (2mg/kg) and inj. rocuronium (0.8 mg/kg). laryngoscopy and intubation is done 120 seconds after induction. Blood pressure pulse rate oxgen saturation is recorded at 5, 10, 13 ( just before intubation) , 14 ( just after intubation), 15, 18, 20 , 25 min after start of infusion. Any intraoperative complication will be noted.Patient will then be extubated at end of procedure after the onset of spontaneous respiration. Statistical anaylsis will be done using various tests like student-t-test and results and conclusion will be made. |