| CTRI Number |
CTRI/2025/10/095706 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of two nasal sprays—dexmedetomidine and butorphanol—to reduce heart and blood pressure rise during anaesthesia for surgery |
|
Scientific Title of Study
|
Intranasal Dexmedetomidine versus Intranasal Butorphanol in attenuation of haemodynamic response during laryngoscopy and 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 |
SAHIL GARG |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PGIMER, Satellite Centre, Sangrur (Pb) |
| Address |
Dr Sahil Garg, Assistant Professor, Department of Anaesthesia and Intensive Care, PGIMER Satellite Centre, Sangrur (Pb)
Sangrur
PUNJAB
148001
India |
| Phone |
9877619896 |
| Fax |
|
| Email |
sahilgarg79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAHIL GARG |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PGIMER, Satellite Centre, Sangrur (Pb) |
| Address |
Dr Sahil Garg, Assistant Professor, Department of Anaesthesia and Intensive Care, PGIMER Satellite Centre, Sangrur (Pb)
Sangrur
PUNJAB
148001
India |
| Phone |
9877619896 |
| Fax |
|
| Email |
sahilgarg79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAHIL GARG |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PGIMER, Satellite Centre, Sangrur (Pb) |
| Address |
Dr Sahil Garg, Assistant Professor, Department of Anaesthesia and Intensive Care, PGIMER Satellite Centre, Sangrur (Pb)
Sangrur
PUNJAB
148001
India |
| Phone |
9877619896 |
| Fax |
|
| Email |
sahilgarg79@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
PGIMER, CHANDIGARH, India
Pin code: 160012 |
| Type of Sponsor |
Research institution |
|
|
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 Sahil Garg |
Post Graduate Institute of Medical Education and Research, Satellite Centre, Sangrur, Punjab |
ROOM NO. 512, Department of Anaesthesia and Intensive Care
Sangrur
PUNJAB |
9877619896
sahilgarg79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER, CHANDIGARH, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Intranasal Dexmedetomidine
2. Intranasal Butorphanol |
Haemodynamic response during laryngoscopy & intubation may lead to serious consequences specially in hypertensive, coronary artery disease patients and in patients having myocardial ischemia, intracranial aneurysm. Till date, no single method is an ideal in attenuation of haemodynamic response during laryngoscopy & intubation. Moreover, use of intravenous agents have more side effect profile as compared to other routes of administration.
Intranasal administration of drugs can be as useful as intravenous route with less adverse effects and have been used in various studies. Both the study drugs have been used individually or in combination with other drugs via intranasal route. But, no previous studies have compared dexmedetomidine and butorphanol via intranasal route prior to administration of general anaesthesia.
So, with the help of this study, we will be able to conclude that whether intranasal dexmedetomidine or intranasal butorphanol can be used to attenuate haemodynamic response and also will come to know which drug is better in attenuating haemodynamic response during laryngscopy & intubation with less side effects between two drugs.
|
| Intervention |
Intranasal Dexmedetomidine versus Intranasal Butorphanol in attenuation of haemodynamic response during laryngoscopy and intubation. |
Haemodynamic response during laryngoscopy & intubation may lead to serious consequences specially in hypertensive, coronary artery disease patients and in patients having myocardial ischemia, intracranial aneurysm. Till date, no single method is an ideal in attenuation of haemodynamic response during laryngoscopy & intubation. Moreover, use of intravenous agents have more side effect profile as compared to other routes of administration.
Intranasal administration of drugs can be as useful as intravenous route with less adverse effects and have been used in various studies. Both the study drugs have been used individually or in combination with other drugs via intranasal route. But, no previous studies have compared dexmedetomidine and butorphanol via intranasal route prior to administration of general anaesthesia.
So, with the help of this study, we will be able to conclude that whether intranasal dexmedetomidine or intranasal butorphanol can be used to attenuate haemodynamic response and also will come to know which drug is better in attenuating haemodynamic response during laryngscopy & intubation with less side effects between two drugs.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I/II
2. Either sex
3. 18 to 60 years of age
4. Elective general surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in study
2. Any allergy to study drugs
3. Patients having comorbidities like cardiac disease & another organ dysfunction
|
|
|
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 |
Comparison of hemodynamic response (HR, BP) between the two groups during laryngoscopy and intubation.
|
During laryngoscopy and intubation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objectives:
1. To compare the adverse effects of both the drugs when administred via intranasal route.
2. To compare the dose reduction of IV induction agent i.e. propofol during induction of general anaesthesia.
3. To compare the MAC reduction of inhalational anaesthetics by observing haemodynamics of patient during surgery.
4. To compare sedation via Ramsay sedation score before induction & after extubation.
5. To compare VAS score after extubation.
6. Time to first rescue analgesia.
|
During Perioperative period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
06/11/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be available by means of publication paper
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Haemodynamic
response during laryngoscopy & intubation may lead to serious consequences
specially in hypertensive, coronary artery disease patients and in patients
having myocardial ischemia, intracranial aneurysm. Till date, no single method
is an ideal in attenuation of haemodynamic response during laryngoscopy &
intubation. Moreover, use of intravenous agents have more side effect profile
as compared to other routes of administration.
Intranasal administration of drugs can be as
useful as intravenous route with less adverse effects and have been used in
various studies. Both the study drugs have been used individually or in
combination with other drugs via intranasal route. But, no previous studies have
compared dexmedetomidine and butorphanol via intranasal route prior to
administration of general anaesthesia.
So, with the help of this study, we will be able
to conclude that whether intranasal dexmedetomidine or intranasal butorphanol
can be used to attenuate haemodynamic response and also will come to know which
drug is better in attenuating haemodynamic response during laryngscopy &
intubation with less side effects between two drugs. |