| CTRI Number |
CTRI/2018/05/014233 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the effect of dexmedetomidine and fentanyl in total intravenous anaesthesia for laparoscopic surgery of gall bladder |
|
Scientific Title of Study
|
Comparative evaluation of dexmedetomidine and fentanyl in total intravenous anaesthesia for laparoscopic cholecystectomy |
| Trial Acronym |
CEDAFTIVAFLC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TABISH HUSNAIN SIDDIQUI |
| Designation |
Resident, Anaesthesiology |
| Affiliation |
MAULANA AZAD MEDICALCOLLEGE |
| Address |
202/12, SHAHJAHANABAD APPT,
SECTOR 11, DWARKA
South West
DELHI
110075
India |
| Phone |
9811865236 |
| Fax |
|
| Email |
tabish2040@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bhadoria |
| Designation |
Director Professor, Dept of Anaesthesiology |
| Affiliation |
MAULANA AZAD MEDICALCOLLEGE |
| Address |
Room no 301, BL Taneja Block,
Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604213 |
| Fax |
|
| Email |
Bhadoriap@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
TABISH HUSNAIN SIDDIQUI |
| Designation |
Resident, Anaesthesiology |
| Affiliation |
MAULANA AZAD MEDICALCOLLEGE |
| Address |
202/12, SHAHJAHANABAD APPT,
SECTOR 11, DWARKA
South West
DELHI
110075
India |
| Phone |
9811865236 |
| Fax |
|
| Email |
tabish2040@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Road, Balmiki Basti, New Delhi, Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Bhadoria |
Maulana Azad Medical College |
Room no 301, BL Taneja Block,
Maulana Azad Medical College, New Delhi
New Delhi
DELHI |
09968604213
Badoriap@yahoo.co.in |
| Dr Tabish Husnain Siddiqui |
Maulana Azad Medical College |
Lok Nayak Hospital, Asaf Ali Road, New Delhi
Central
DELHI |
9811865236
tabish2040@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 |
ASA Grade 1 and 2
Age 18-60 yrs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Alpha-2A adrenoceptor agonist
It was administered during induction of anaesthesia at 1 microgram per kilogram bolus dose intravenous over 10 minutes followed by a continuous infusion of DEXMEDETOMIDINE at 0.5 microgram per kilogram per hour for the duration of surgery. |
| Comparator Agent |
Fentanyl |
Potent opioid
It was started during induction at 2 microgram per kilogram bolus dose intravenous over ten minutes followed by 1 microgram per kilogram per hour intravenous dose for the duration of the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
ASA grade 3 and 4
Duration of surgery more than 1.5 hours
BMI more than equal to 30
patient on anti-hypertensive medication
anticipated difficult airway
history of substance abuse or patient on psychotropic drugs
history suggestive of allergy to inj propofol or to other drugs under study |
|
|
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 |
| time to Post anaesthesia discharge score(PADSS) ≥ 9 |
assessment every 10 minutes in post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative hemodynamics |
intraoperative |
| total propofol consumption |
intraoperative |
| on table recovery time |
time taken from stopping of propofol infusion till the time patient responds to verbal command |
| number of patients requiring rescue analgesia |
postoperative |
| time to rescue analgesia |
time between admission to PACU and first postoperative analgesic requirement |
| number of patients requiring rescue antiemetic |
postoperative |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/10/2015 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Comaparative evaluation in the efficacy of dexmedetomidine and fentanyl in total intravenous anaesthesia for laparoscopic cholecystectomies regarding post anaesthesia discarge score, intraoperative hemodynamics, on table recovery time, total propofol consumption, number of patients requiring rescue analgesia, time to rescue analgesia, number of patients requiring rescue antiemetic |