| CTRI Number |
CTRI/2026/02/104530 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| 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 COMPARING TWO DRUG USED TO CONTROL HEART RATE AND BLOOD PRESSURE DURING PLACEMENT OF BREATHING TUBE IN SURGERY |
|
Scientific Title of Study
|
Comparison Between Dexmedetomidine And Remifentanil For Attenuation Of Hemodynamic Response To Laryngoscopy And Tracheal Intubation |
| 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 Shibani Kairi |
| Designation |
Post Graduate Trainee |
| Affiliation |
Silchar medical college and hospital |
| Address |
Department of Anaesthesiology and Critical Care , Ghungoor, ,Silchar ,Cachar ,Assam
Cachar
ASSAM
788014
India |
| Phone |
9395141193 |
| Fax |
|
| Email |
shibanik284@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneeta Dutta |
| Designation |
HOD and professor |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care , Ghungoor, ,Silchar ,Cachar ,Assam
Cachar
ASSAM
788014
India |
| Phone |
7002826884 |
| Fax |
|
| Email |
drsuneetadutta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneeta Dutta |
| Designation |
HOD and professor |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care , Ghungoor, ,Silchar ,Cachar ,Assam
Cachar
ASSAM
788014
India |
| Phone |
7002826884 |
| Fax |
|
| Email |
drsuneetadutta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar Medical College and Hospital,Cachar, PIN -788014 ,Assam, India |
|
|
Primary Sponsor
|
| Name |
Dr Shibani Kairi |
| Address |
Department of Anaesthesiology and Critical Care , Ghungoor, ,Silchar,Pin -788014 ,Cachar ,Assam, India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Shibani Kairi |
Silchar Medical College And Hospital |
Department of Surgery,Silchar Medical College And Hospital,Cachar, Assam
Cachar
ASSAM |
9395141193
shibanik284@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Infusion Dexmedetomidine |
infusion dexmedetomidine is given at a dose of 1 microgram of body weight over a period of 10 minutes before intubation |
| Comparator Agent |
infusion normal saline |
infusion normal saline given before intubation |
| Intervention |
Infusion Remifentanil |
Infusion Remifentanil is given at a dose of 1 microgram of body weight over a period of 10 minutes before intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 AND ASA2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine and compare effect of dexmedetomidine and reminfentanil in attenuation of haemodynamic response like systolic blood pressure ,heart rate ,saturation in upper abdominal surgery. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| access side effect with dexmedetomidine & remifentanil |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/03/2026 |
| 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 Applicable |
| 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
|
Laryngoscopy and endotracheal intubation are essential components of general anesthesia , facilitating airway control and mechanical ventilation .However these procedure are potent stimuli that can evoke marked sympathetic and hemodynamic response , characterized by tachycardia, hypertension and arrhythmias . These reflex cardiovascular changes result primarily from the stimulation of the supraglottic and subglottic structure , leading to a surge in catecholamine release mediated by sympathetic activation. Although transient in healthy individuals, these responses may have deleterious effects in cardiovascular or cerebrovascular disease, including myocardial ischemia ,heart failure exacerbation, or intracranial hypertension. Dexmedetomidine selectively in alpha -2 adrenergic located in the locus coeruleus of the brainstem and peripheral sympathetic nerve terminals .Activation of these receptors results in the inhibition of norepinephrine release, decrease sympathetic activity ,and enhancement of parasympathetic tone. Remifentanil is rapidly acting with short context -sensitive half -life ,and metabolism by non specific plasma and tissue esterases . It exerts it effect by activating opioid receptors in the central nervous system ,reducing sympathetic outflow and inhibiting catecholamine release. |