| CTRI Number |
CTRI/2023/02/050146 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| 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
|
Reduction of response during visualisation of throat and passing a tube through the wind pipe with a different injection |
|
Scientific Title of Study
|
Attenuation of haemodynamic responses to laryngoscopy and intubation with intravenous dexmedetomidine: A randomised controlled trial on comparison between two doses. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anna Mary George |
| Designation |
M D POST GRADUATE STUDENT |
| Affiliation |
ST JOHNS MEDICAL COLLEGE,BANGALORE |
| Address |
Department of Anaesthesia,
St. John’s Medical College Hospital, Sarjapur Road,
Bangalore – 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
8606109201 |
| Fax |
|
| Email |
anna92kap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SATHYANARAYANA P S |
| Designation |
Professor |
| Affiliation |
ST JOHNS MEDICAL COLLEGE,BANGALORE |
| Address |
Department of Anaesthesia,
St. John’s Medical College Hospital, Sarjapur Road,
Bangalore – 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9448066128 |
| Fax |
|
| Email |
sathyanarayananair@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anna Mary George |
| Designation |
M D POST GRADUATE STUDENT |
| Affiliation |
ST JOHNS MEDICAL COLLEGE,BANGALORE |
| Address |
Department of Anaesthesia,
St. John’s Medical College Hospital, Sarjapur Road,
Bangalore – 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
8606109201 |
| Fax |
|
| Email |
anna92kap@gmail.com |
|
|
Source of Monetary or Material Support
|
| ST.JOHNS MEDICAL COLLEGE HOSPITAL,BANGALORE-560034
|
|
|
Primary Sponsor
|
| Name |
Anna Mary George |
| Address |
Department of Anaesthesia,
St.Johns Medical College,Sarjapur Road,560034 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 ANNA MARY GEORGE |
St. Johns medical college hospital, |
Otperation theatre complex,
St. John’s Medical College Hospital, Sarjapur Road,
Bangalore – 560034
Bangalore
KARNATAKA |
8606109201
anna92kap@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 |
Dexmedetomidine |
Dexmedetomidine is an α-2 agonist which has property of good anxiolysis, sedation and analgesic action.This study compares different doses of dexmedetomidine -0.5 mcg/kg and 0.75 mcg/ kg intravenous with normal saline given over 10 minutes before intubation to arrive at an optimal dose of dexmedetomidine for attenuation of stress response to laryngoscopy and endotracheal intubation |
| Comparator Agent |
Placebo |
this study compares different doses of dexmedetomidine with normal saline,which is the placebo to arrive at an optimal dose of dexmedetomidine for attenuation of stress response to laryngoscopy and endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) Physical Status 1 and 2
Age 18 –59 years
Posted for elective surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients who are physically dependent on narcotics
Those with a history of bronchial asthma, drug or alcohol abuse.
Known drug allergy to either clonidine or dexmedetomidine,
Cerebrovascular, neurologic, respiratory or ischemic heart disease (history of angina, previous myocardial infarction)
Renal and hepatic dysfunction.
Patients on alpha-blockers, antidepressants, anxiolytics, anticonvulsant or antipsychotics
Any predicted difficult airway
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To arrive at an optimal dose of IV dexmedetomidine by comparing different doses of the drug with normal saline in terms of attenuation of haemodynamic stress response to laryngoscopy and endotracheal intubation |
Recorded at 1, 3 , 5 and 10 min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the sedation after the drug infusion based on Ramsay sedation score. |
Recorded at 1, 3 , 5 and 10 min after intubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/03/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a cross sectional study conducted at St. Johns medical college hospital in the year 2022-2023 .Written informed consent of patient or attenders will be taken prior to participation in the study. General anaesthesia involves placing a tube in your windpipe in order to help you breathe during surgery .This placement of the tube is associated with an increase in your blood pressure and heart rate which can be stressful for your body. Dexmedetomidine is a drug which has property of good anxiolysis, sedation and analgesic action. It also decreases the dose and Minimum Alveolar Concentration (MAC) value of inhalational anaesthetic agents and prevents postoperative nausea, vomiting and shivering and allows psychomotoric function to be preserved while letting the patient rest comfortably. This study compares different doses of dexmedetomidine and comparing it with normal saline to arrive at an optimal dose of dexmedetomidine for attenuation of stress response to laryngoscopy and endotracheal intubation. Secondary objective is to assess the sedation after the drug infusion based on Ramsay sedation score. |