| CTRI Number |
CTRI/2020/07/026918 [Registered on: 30/07/2020] Trial Registered Prospectively |
| Last Modified On: |
29/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing nebulised lignocaine and intravenous dexmedetomidine in response of airway instrumentation. |
|
Scientific Title of Study
|
Comparison of attenuation of hemodynamic pressor response to laryngoscopy and endotracheal intubation with intravenous Dexmedetomidine versus nebulized 4% solution of lignocaine versus combination of Both in patients undergoing laparoscopic cholecystectomy surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zeeshan Haider warsi |
| Designation |
Postgraduate |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Department of Anesthesiology,
1st floor IMS and SUM Hospital,
Khandagiri, Shyampur, Bhubaneshwar, Oddisha
Khordha
ORISSA
751003
India |
| Phone |
7542097805 |
| Fax |
|
| Email |
zeeshanamu89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Sriramka |
| Designation |
Assistant Professor |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Department of Aneshthesiology,
1st Floor, IMS and SUM Hospital,Shyampur, Bhubaneshwar, Odissa
Khordha
ORISSA
751003
India |
| Phone |
7751007807 |
| Fax |
|
| Email |
bhavna.sriramka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zeeshan Haider warsi |
| Designation |
Postgraduate |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Department of Anesthesiology, 1st Floor , IMS and SUM Hospital , Shyampur , Khandagiri , Bhubaneshwar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
7542097805 |
| Fax |
|
| Email |
zeeshanamu89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, IMS and SUM HOSPITAL |
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOSPITAL |
| Address |
K8, kalinganagar, Bhubaneshwar 751003 |
| 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 |
| ZEESHAN HAIDER WARSI |
IMS AND SUM HOSPITAL |
Department of Anesthesia,1st floor, IMS and SUM Hospital, K8- KALINGANAGAR, Shyampur, BHUBANESHWAR
Khordha
ORISSA |
7542097805
zeeshanamu89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS and SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
4 % lignocaine |
Dose - 3mg/kg
Route - via a face mask and
cirrus nebulizer with
Oxygen
Duration - 10 minutes or till
the whole drug is
used up |
| Comparator Agent |
DEXMEDETOMIDNE |
Dose - 1mcg/kg
Route - intravenous infusion
Duration - 10 minutes before
Induction of
Aneshtesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA Grade I - II status posted for laparoscopic Cholecystectomy Surgery,Securing airway within 30 seconds,Airway examination: Mallampatti Grade- 1,2; Neck Extension > 6.5cm, Mouth Opening> 3 fingers, Age group: 18 to 50 years
|
|
| ExclusionCriteria |
| Details |
1. The patients who did not give consent
2. The American society of anesthesiology (ASA) physical status > II
3. Weight: <40kg or >70kg
4. Anticipated difficult airway (Mallampati Grade-3,4; Cormack-Lehane Grade-3,4), short neck
5. Patients with history of any medication or substance abuse
6. Age: <18years or >50 years
7. BMI more than 30
8. Height: <150cm or >180cm
9. Base line Heart rate: ≤60 bpm or ≥90bpm.
10. Baseline Blood pressure: ≤90/50(65) mmhg or ≥140/85(105) mmhg.
11. Smokers, history of any respiratory disease, gastro esophageal reflux disease.
12. Patients taking antihypertensive or any alpha-2 agonist
13. No postural hypotension
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the change in heart rate and mean blood pressure( in terms of 20% rise from baseline values) in three groups of patients undergoing laparoscopic Cholecystectomy, namely :
1. Group “D†(intravenous Dexmedetomidine group),
2. Group “L†(nebulized 4% Lignocaine) and
3. Group “DL†(combination of Both)
|
Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Pressure measured at Baseline, Before Nebulization ,After Nebulizaton, Before Infusion, Before Laryngoscopy and After Intubation at 1, 3, 5, 7, 10 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
0 |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Henderson J. Airway management in the adult. In: Miller RD, editor. Miller’s Anesthesia. 7th ed. Philadelphia: Elsevier Churchill Livingstone; 2010. p. 1573-610.
2. King BD, Harris LC Jr., Greifenstein FE, Elder JD Jr., Dripps RD. Reflexcirculatory responses to direct laryngoscopy and tracheal intubationperformed during general anesthesia. Anesthesiology 1951;12:556‑66
3. Ng WS. Pathological effects of tracheal intubation. In: Latto IP, Rosen M editors. Difficulties in Tracheal Intubation. London: Bailliere Tindall;1985. p. 14.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To observe and compare the effectiveness of preoperative
administration of intravenous Dexmedetomidine versus Nebulization of 4%
solution of Lignocaine versus combination of both in attenuating the
hemodynamic pressor response to laryngoscopy and endotracheal intubation
patients undergoing laparoscopic Cholecystectomy Surgery. To find out the change in heart rate and mean
blood pressure( in terms of 20% rise from baseline values) in three groups of
patients undergoing laparoscopic Cholecystectomy, namely : 1. Group
“D†(intravenous Dexmedetomidine group), 2. Group
“L†(nebulized 4% Lignocaine) and 3. Group
“DL†(combination of Both) Group “D†will receive intravenous Dexmedetomidine 1mcg/kg
infusion over 10 minutes before induction of anesthesia and receive Normal
Saline 0.9% in Nebulization (assuming Normal Saline to be 4% Lignocaine) in the
preoperative room. Group “L†will receive Nebulization with 3mg/kg solution of 4%
Lignocaine via a face mask and cirrus nebulizer with Oxygen at the rate of 8
L/min in the preoperative room and Normal Saline infusion in infusion syringe
over 10min before induction(assuming it to be
intravenous Dexmedetomidine infusion) in the operative room . Group “DL†group will receive Nebulization with 3mg/kg solution of
4% Lignocaine via a face mask and cirrus nebulizer with Oxygen at the rate of 8
L/min in the preoperative room and intravenous Dexmedetomidine 1mcg/kg infusion
over 10 minutes in the operative room.
|