| CTRI Number |
CTRI/2025/04/084441 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of Fentanyl to that of Dexmedetomidine against stress response to endotracheal intubation in adult patients. |
|
Scientific Title of Study
|
A Randomized study to compare the effect of single pre-operative dose of dexmedetomidine and fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sendhooran S |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex,2nd Floor, Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia,Vadodara, Gujarat,391760 India
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9123509141 |
| Fax |
|
| Email |
sendhoo05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex,2nd Floor, Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia,Vadodara, Gujarat,391760 India
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9825038233 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General OT Complex,2nd Floor, Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia,Vadodara, Gujarat,391760 India
Vadodara
GUJARAT
391760
India
GUJARAT
391760
India |
| Phone |
9825038233 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya,
Vadodara, Gujarat,India Pincode-391760 |
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodiya,Pipariya,Vadodara, Gujarat,India Pincode-391760 |
| 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 |
| Dr Nilesh Shah |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Smt Bhikiben Kanjibhai
Shah Medical Institute
and Research Centre,
Sumandeep
Vidyapeeth,
Waghodiya,Pipariya,
Vadodara,Gujarat
391760,India
Vadodara
GUJARAT
Vadodara
GUJARAT |
9825038233
nileshshah730@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical 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 |
Intravenous injection of Dexmedetomidine 0.5mcg/kg |
Intravenous injection of Dexmedetomidine 0.5mcg/kg over 10 minutes prior to induction of anaesthesia to the patient and to monitor haemodynamic changes of the patients at baseline, during administration of the study drug, after administration of study drug, during laryngoscopy, after intubation and at 1,3,5,10,15 minutes post intubation.
|
| Comparator Agent |
Intravenous injection of Fentanyl 1.5mcg/kg |
Intravenous injection of Fentanyl 1.5mcg/kg over 10 minutes prior to induction of anaesthesia to the patient and to monitor haemodynamic changes of the patients at baseline, during administration of the study drug, after administration of study drug, during laryngoscopy, after intubation and at 1,3,5,10,15 minutes post intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign informed consent.
Male or female patients between ages of 18 to 60 years.
Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
Patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia.
Patient having mouth opening more than 3cm
Patient with Malampatti grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study.
Patients belonging to ASA status 3 and 4
Patients having contraindication to endotracheal intubation/general anaesthesia.
Patient having mouth opening less than 3cm.
Patient with Mallampati grade 3 and 4.
Body mass index more than 30 kg.m2.
patients taking anxiolytics, sedatives, antipsychotic, or antiepileptic drugs.
Patients with history of muscular disorder, myositis or any local infection.
Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta blockers.
Patients with cerebrovascular, hepatic and renal diseases.
Psychiatric patients.
Patients with history of allergy to an alpha 2 adrenergic agonist and synthetic opioids.
Pregnancy and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of single pre operative dose of Dexmedetomidine and Fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia |
To compare the effect of single pre operative dose of Dexmedetomidine and Fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia (Baseline parameters before administration of the study drug, after 5 minutes during the administration of the study drug, just after administration of the study drug, after induction of anaesthesia, after intubation, and at 1,3,5,10,15 minutes post intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient haemodynamic parameters during extubation.
Post operative Sedation effect |
Just after extubation and 15,30,60 minutes post extubation. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
20/04/2025 |
| 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="6"
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
|
Randomized and observational study to compare the effect of single pre-operative dose of dexmedetomidine and fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia. This study shall further help us to conclude a better drug for controlled attenuation of haemodynamics without any major side effects. |