| CTRI Number |
CTRI/2025/08/092819 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing two medicines to control increase in heart rate and blood pressure during breathing tube insertion |
|
Scientific Title of Study
|
Comparison of dexmedetomidine and fentanyl in attenuation of haemodynamic response following laryngoscopy and endotracheal 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 Deepak Thapa |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH, Sector-32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121524 |
| Fax |
|
| Email |
dpkthapa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Thapa |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH, Sector-32B, Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121524 |
| Fax |
|
| Email |
dpkthapa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samriti Sood |
| Designation |
Postgraduate Student |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH, Sector-32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7018676013 |
| Fax |
|
| Email |
samritisood710@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh sector 32B, Chandigarh, India -160030 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh,Sector-32B, Chandigarh, India-160030 |
| 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 |
| Dr Deepak Thapa |
Government Medical College and Hospital, Chandigarh |
Department of Anaesthesia and Intensive Care, Level-5, Room No 521, GMCH, SEctor-32B, Chandigarh
Chandigarh
CHANDIGARH |
9646121524
dpkthapa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College and Hospital, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous dexmedetomidine |
Intravenous dexmedetomidine in a dose of 1 mcg/kg in 100 mL normal saline over 10 minutes will be administered prior to induction of general anaesthesia. |
| Comparator Agent |
Intravenous fentanyl |
Intravenous fentanyl in a dose of 2 mcg/kg in 100 mL normal saline over 10 minutes will be administered prior to induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in age group of 18-60 years.
2.American Society of Anesthesiologists (ASA) Status I and II.
3.Patients undergoing laparoscopic cholecystectomy requiring general anaesthesia with endotracheal intubation.
|
|
| ExclusionCriteria |
| Details |
1. Refusal of patient.
2. Morbid obesity (BMI more than 35 kg/m2).
3. Surgery duration more than 3 hours.
4. Patients at increased risk of aspiration like GERD, peptic ulcer, non-fasting status.
5. Known or anticipated difficult tracheal intubation or facemask ventilation.
6. Cardiorespiratory or cerebrovascular disease.
7. Pregnant or lactating females.
8. Contraindications or allergy to dexmedetomidine and fentanyl.
9. Patient with coagulopathy and bleeding disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the change in HR, systolic blood pressure (SBP), diastolic blood pressure (DBP), MAP and SpO2 between the two groups of patients during laryngoscopy and endotracheal intubation. |
Baseline, immediately after intervention, at the time of ETT insertion, at 1 min, 3 min, 5 min, 8 min, 10 min after endotracheal tube insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study post operative sedation according to Ramsay Sedation Score (RSS).
2. To study adverse effects : Bradycardia, hypotension, nausea, vomiting, respiratory depression.
3. To study haemodynamic parameters in post operative period (Heart rate, diastolic BP, systolic BP, Mean arterial pressure, spO2.
|
Baseline parameters in PACU, at 5 min, 10 ,in, 15 min and 30 min in post operative period. |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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
|
The study will
compare the effect of dexmedetomidine and fentanyl on haemodynamic parameters
(Heart rate, blood pressure, oxygen saturation) following laryngoscopy and
endotracheal intubation in patients posted for laparoscopic cholecystectomy.
Laryngoscopy and endotracheal intubation after induction of general anaesthesia
is associated with a stress response leading to rise in heart rate and blood
pressure. Fentanyl and dexmedetomidine have been used to mitigate this stress
response in patients undergoing general anaesthesia. This study aims to compare
the efficacy of dexmedetomidine and fentanyl in attenuation of haemodynamic
changes and to also assess the sleep scores in the post operative period. |