| CTRI Number |
CTRI/2018/03/012555 [Registered on: 14/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparing the effect of two drugs (Dexmedetomidine and lignocaine) in reducing the rise in heart rate, blood pressure during recovery from anaesthesia |
|
Scientific Title of Study
|
Comparison of intravenous Dexmedetomidine with intravenous Lignocaine in attenuating haemodynamic responses to extubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chiranjeevi vallamsetty |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical college and hospital |
| Address |
Department of Anaesthesiology, KMC, Manipal Manipal, udupi
district, Karnataka-576104
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9845544346 |
| Fax |
|
| Email |
drchiru2k7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Bawdekar |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Medical college and hospital |
| Address |
Department of Anaesthesiology, KMC, Manipal Manipal, udupi
district, Karnataka-576104
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9448866819 |
| Fax |
|
| Email |
rashbawdekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Bawdekar |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Medical college and hospital |
| Address |
Department of Anaesthesiology, KMC, Manipal Manipal, udupi
district, Karnataka-576104
Udupi
KARNATAKA
576104
India
Hassan
KARNATAKA
576104
India |
| Phone |
9448866819 |
| Fax |
|
| Email |
rashbawdekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Kasturba College and Hospital, Manipal, Udupi,
Karnataka |
|
|
Primary Sponsor
|
| Name |
PG Thesis fund KMC Manipal |
| Address |
Kasturba medical college and hospital, Manipal, udupi district,
Karnataka-576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chiranjeevi vallamsetty |
Kasturba Medical College and Hospital |
Department of
Anaesthesiology, OT
complex, 1st floor,
Manipal
Udupi
KARNATAKA
Udupi
KARNATAKA |
9845544346
drchiru2k7@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 |
Age group between 18 and 65years of either
gender belonging to ASAPS 1 or 2 undergoing
Laproscopic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D |
Patients in this group will receive 0.5 ug/kg of Dexmedetomidine intravenously (rounded off to the nearest 5 ug) in 10 ml of 0.9% NaCl over 5 minutes at the end of surgery |
| Comparator Agent |
Group L |
Patients in this group will receive 1.5 mg/kg of 2% preservative free Lignocaine intravenously (rounded off to the nearest 10 mg) in 10 ml of 0.9% NaCl over 5 minutes at the end of surgery |
| Comparator Agent |
Group S |
Patients in this group will receive 10 ml of 0.9% NaCl over 5 minutes at the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
to ASA-PS I and II undergoing elective laproscopic surgeries requiring general anaesthesia and endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Suspected allergy to study drugs,
Difficult airway,
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and compare heart rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressure in the periextubation period |
Heart rate, Systolic, diastolic and mean arterial pressures at intervals
Baseline(just before drug administration)
After 5 min (end of drug administration)
Post extubation at 1, 2, 3, 4, 5 and 10 min.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ramsay sedation score
Time to extubaton
Any adverse effects |
Ramsay sedation score(assessed at intervals of 0min, 5min, 10 min, 30 min, 60 min)
Time to extubation(time taken from administration of drugs to antagonize residual neuromuscular blockade till the time of removal of endotracheal tube)
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2017 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is Prospective Double blinded Randomized Controlled study. Main aim is to compare the efficacy of intravenous Dexmedetomidine and Lignocaine in attenuating haemodynamic responses to tracheal extubtion and emergence from general anaesthesia. primary outcomes are Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure during periextubation period. secondary outcomes is to observe sedation score and time to extubation |