| CTRI Number |
CTRI/2020/03/024088 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing efficacy of two different doses of DEXMEDETOMIDINE for supression of haemodynamic responses to laryngoscopy with BIS monitoring |
|
Scientific Title of Study
|
A prospective randomised double blinded study to compare efficacy of two different doses of dexmedetomidine for attenuation of pressor responses to laryngoscopy and endotracheal intubation under bispectral index- controlled general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HarshaKN |
| Designation |
Postgraduate student |
| Affiliation |
Jawahar lal nehru medical college, Ajmer, Rajasthan |
| Address |
Department of anaesthesiology, JLN medical college, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9480114969 |
| Fax |
|
| Email |
hunterzeus16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor , HOD and Guide |
| Affiliation |
Jawahar lal nehru medical college, Ajmer, Rajasthan |
| Address |
Department of anaesthesiology, JLN medical college, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor , HOD and Guide |
| Affiliation |
Jawahar lal nehru medical college, Ajmer, Rajasthan |
| Address |
Department of anaesthesiology, JLN medical college, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN Medical College Ajmer
opp. Patel Stadium, Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN Medical College Ajmer |
| Address |
Department of anaesthesiology, JLN medical college, Ajmer, Rajasthan |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsha |
JLN Medical College, Ajmer |
Department of anaesthesiology, JLN medical college, Ajmer, Rajasthan
Ajmer
RAJASTHAN |
9480114969
hunterzeus16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, JLN Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Attenuation of pressor responses to laryngoscopy and endotracheal intubation under bispectral index- controlled general anaesthesia |
Haemodynamic changes during laryngoscopy and endotracheal intubation is assessed
Duration of study is around 1 year |
| Comparator Agent |
To compare attenuation of the pressor responses to laryngoscopy and endotracheal intubation with two varying doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) under bispectral index- controlled general anaesthesia |
compare the efficacy of two different doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) intravenous infusion in 100ml NS over 15 minutes before induction along with control group to find out optimal dose of dexmedetomidine in attenuation of pressor response to largyngoscopy and intubation when depth of anaesthesia is maintained at bi-spectral index (BIS) range of 40-60 in all patients |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18 and 55 years.
Body weight 50 to 70 kg.
Patients belonging to ASA (American Society of Anaesthesiologists) physical status class-I and II.
Patients undergoing elective surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal.
Uncooperative patients.
Any known hypersensitivity or contraindication to Dexmedetomidine.
History of convulsion, bleeding disorder, severe neurological deficit, thyroid disorder.
Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
Patients having a history of significant neurological, psychiatric, or neuromuscular disorders.
Anticipated difficult airway which requires >20seconds to intubate.
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|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of our study will be to assess haemodynamic changes (HR, SBP, DBP, MAP) from baseline upto 30 min after intubation. |
Duration of study is around 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
secondary outcome will be assessment of sedation of patient using Ramsay Sedation Score (RSS) pre-operatively i.e before infusion with Dexmeditomidine and after completion of infusion. Intraoperative DOSAGE REQUIREMENT OF PROPOFOL for induction will also be noted in our study and the effect of two varying doses of dexmedetomidine on intraoperative DOSAGE REQUIREMENT OF PROPOFOL will be assessed.
Any associated SIDE EFFECTS/COMPLICATIONS |
Duration of study is around 1 year |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/03/2020 |
| Date of Study Completion (India) |
02/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
"Efficacy of dexmedetomidine in
attenuating pressor response to
laryngoscopy and endotracheal
intubation under bispectral
index controlled anesthesia: A
prospective randomized double-
blinded study." Ain-Shams
Journal of Anesthesiology 15, no.
1 (2023). |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The aim of our study is to compare attenuation of the pressor responses to laryngoscopy and endotracheal intubation with two varying doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) under bispectral index- controlled general anaesthesia in patients undergoing various elective surgeries under general anaesthesia in terms of :-
PRIMARY OBJECTIVES : Haemodynamic changes (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure)
SECONDARY OBJECTIVES : Sedation score (RSS) before and after dexmedetomidine infusion Dose requirement of induction agent (Propofol) Complications/side effects, if any
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