| CTRI Number |
CTRI/2020/07/026594 [Registered on: 15/07/2020] Trial Registered Prospectively |
| Last Modified On: |
10/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study effect of dexmedetomidine drug during laparoscopic cholecystectomy |
|
Scientific Title of Study
|
A study to evaluate the effect of dexmedetomidine on haemodynamic response in untreated stage1 hypertensive patients undergoing laproscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSanjay Johar |
| Designation |
Professor |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of anaesthesia and critical care
Pt B.D.Sharma PGIMS
ROHTAK
Department of Anesthesiology and Critical Care
Pt BD SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
anishsingh79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSudesh |
| Designation |
Pg student |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of anaesthesia and critical care
Pt B.D.Sharma PGIMS
ROHTAK
Department of Anesthesiology and Critical Care
Pt BD SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
dr.sudeshkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSudesh |
| Designation |
Pg student |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of anaesthesia and critical care
Pt B.D.Sharma PGIMS
ROHTAK
Department of Anesthesiology and Critical Care
Pt BD SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
dr.sudeshkr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pt B DSHARMA PGIMS ROHTAK |
| Address |
Department of anaesthesia and critical care
Pt B.D.Sharma PGIMS, Rohtak
ROHTAK |
| Type of Sponsor |
Government 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 Sudesh Kumar |
Pt BD Sharma PGIMS, Rohtak |
Department of Anesthesiology and Critical Care, PGIMS Rohtak
Rohtak
HARYANA |
07988818847
dr.sudeshkr@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: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine infusion |
After Loading dose of 1mcg per kg over 10 minutes ,dexmedetomidine at rate of 0.2mcg/kg/hr started through intraoperative period |
| Comparator Agent |
Normal saline infusion |
Normal saline infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1&2
Either sex
Posted for laproscopic cholecystectomy
Stage 1 hypertensive patients,not on any medication |
|
| ExclusionCriteria |
| Details |
Patients with difficult airway
Stage 2 hypertensive
Patients on antihypertensive medication
Patients with cardiac,renal,hepatic or endocrine disease
Pregnant or morbid obese
Allergic to dexmedetomidine |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate effect of dexmedetomidine on hemodynamic response to laryngoscopy,intubation,pneumoperitoneum and extubation in stage 1 hypertensive patients undergoing laproscopic cholecystectomy |
To investigate effect of dexmedetomidine on hemodynamic response to laryngoscopy,intubation,pneumoperitoneum 15 minutes,release of pneumoperitoneum and extubation in stage 1 hypertensive patients undergoing laproscopic cholecystectomy during perioperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe time to extubate trachea,time to first rescue analgesia and post operative sedation score at 1 min, 15 minutes, 30 minutes and 60 minutes. |
Any adverse effects like hypotension,bradycardia and excessive sedation during perioperative period and sedation score at 1 minute, 15 minute,30 minutes and 60 minutes. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2020 |
| Date of Study Completion (India) |
29/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present prospective study will be conducted in the depatment of anaesthesia and critical care,PGIMS,ROHTAK.Written informed consent will be taken from patients included.The study is to investigate the effect of dexemedetomidine on hemodynamic response in untreated stage1 hypertensive patients undergoing laproscopic cholecystectomy.The changes in HR & MAP during laryngoscopy,intubation,creation & release of pneumoperitonium and extubation will be noted.Data will be compiled and analysed with appropriate statistical test. |