| CTRI Number |
CTRI/2020/06/026078 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
18/06/2020 |
| 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
|
Study to compare different drugs with different routes in routine surgeries to compare blood circulation responses during tracheal intubation |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF INTRAVENOUS CLONIDINE , LIGNOCAINE NEBULIZATION AND A COMBINATION OF BOTH FOR ATTENUATION OF PRESSOR RESPONSE TO LARYNGOSCOPY AND TRACHEAL INTUBATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Chawla |
| Designation |
Professor Department Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department of Anaesthesiology and critical care sgrdimsar vallah
amritsar Sri Guru Ramdas Institute Of Medical Sciences And
Research Vallah
Amritsar
PUNJAB
143501
India |
| Phone |
9915530033 |
| Fax |
|
| Email |
drchawla30@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Chawla |
| Designation |
Professor Department Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department of Anaesthesiology and critical care sgrdimsar vallah
amritsar Sri Guru Ramdas Institute Of Medical Sciences And
Research Vallah
PUNJAB
143501
India |
| Phone |
9915530033 |
| Fax |
|
| Email |
drchawla30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manbir Kaur |
| Designation |
P G Resident Department Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department of Anaesthesia Sri guru ram das institute of health
sciences and research,vallah
Amritsar
PUNJAB
143501
India |
| Phone |
7973136682 |
| Fax |
|
| Email |
manbirdeol201647@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia Sri Guru Ram Das Institute Of Medical Sciences And Research Vallah
Amritsar |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department of Anaesthesiology and Critical Care Sgrdimsar Vallah Amritsar Sri Guru Ramdas Institute Of Medical Sciences And Research Vallah Amritsar PUNJAB 143501 |
| 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 Sunil Chawla |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
Main Operation Theatre Department of Anaesthesiology and critical care sgrdimsar
Vallah Amritsar PUNJAB 143501 India
Amritsar
PUNJAB
143501
India
Amritsar
PUNJAB |
9915530033
drchawla30@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee Sri Guru Das Institute Of Medical Sciences And Reasearch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous clonidine versus lignocaine nebulization for attenuation of pressor response to laryngoscopy and tracheal intubation in patients undergoing elective surgeries |
to evaluate the efficacy of intravenous clonidine,lignocaine nebulization and a combination of both for attenuation of pressor response to laryngoscopy and tracheal intubation in terms of heart rate, blood pressure,oxygen saturation and ECG changes |
| Comparator Agent |
to compare efficacy of intravenous clonidine versus lignocaine nebulization versus combination of both for attenuation of pressor response to laryngoscopy and tracheal intubation in patients undergoing elective surgeries |
to evaluate the efficacy of intravenous clonidine, lignocaine nebulization and a combination of both for attenuation of pressor response to laryngoscopy and tracheal intubation in terms of herat rate,blood pressure,oxygen saturation and ECG changes.Study will be conducted on 75 patients posted for elective surgeries with 3 groups of 25 each.Group A will be given intravenous clonidine 1mcg/kg diluted to 10 ml and nebulization with normal saline of 0.075ml/kg. Group B will be given intravenous clonidine 1 mcg /kg and nebulization with lox 4% 0.075ml/kg. Group C will be given intravenous normal saline 10ml and nebulization with lox 4% 0.075ml/kg. Every drug should be given 15 minutes prior to induction. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 or 2
Mallampatti grade 1 or 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Anticipated and unanticipated difficult airway
Hypertension, ischemic heart disease,pregnancy and patients receiving antihypertensives, sympathomimetics,antidepressants and vagomimetics
Known allergy to study drugs |
|
|
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 Evaluate The Efficacy Of Intravenous Clonidine And Lignocaine Nebulization For Attenuation Of Pressor Response To Laryngoscopy And Tracheal Intubation In Terms Of Heart Rate,Blood Pressure,Oxygen Saturation And ECG Changes |
Baseline,Pre-induction,Every 1 Min For First 10 Minutes And Then Every 10 Minutes Till The End Of Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study The Incidence Of Intra-operative Complications Associated With Study Drugs |
Intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
25/06/2020 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
a placebo controlled study to compare the effect of intravenous clonidine, lignocaine nebulization and a combination of both for attenuation of pressor response to laryngoscopy and tracheal intubation in terms of heart rate, blood pressure, oxygen saturation and ECG changes. Study will be done on 75 patients posted for elective surgeries under general anaesthesia with 25 patients in each 3 groups. Group C will receive intravenous clonidine 1 mcg/kg and nebulization with 0.075 ml/kg normal saline. Group L will receive intravenous normal saline 10 cc and nebulization with 3 mcg/kg (0.075 ml/kg) of 4% lignocaine. Group CL will receive intravenous clonidine 1 mcg/kg and nebulization with 3 mcg/kg (0.075 ml/kg) of 4 % lignocaine. Study drugs will be given 15 min prior to intubation. Intraopertaive hemodynamic parameters and complications will be noted.
|