| CTRI Number |
CTRI/2019/03/018003 [Registered on: 08/03/2019] Trial Registered Prospectively |
| Last Modified On: |
01/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Dexmedetomidine and Fentanyl on effective concentration of Propofol for the insertion of airway device. |
|
Scientific Title of Study
|
Comparision of the Effect Between Dexmedetomidine And Fentanyl on Median Effective Concentration (EC 50) of Propofol for I gel insertion: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankur Luthra |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756500 |
| Fax |
|
| Email |
zazzydude979@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankur Luthra |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756500 |
| Fax |
|
| Email |
zazzydude979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankur Luthra |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756500 |
| Fax |
|
| Email |
zazzydude979@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ankur Luthra
Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Ankur Luthra |
| Address |
Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ankur Luthra |
PGIMER |
4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9868057732
zazzydude979@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D |
Group D - would receive intravenous dexmedetomidine 0.5 mcg/kg over 5 mins prior to induction |
| Comparator Agent |
Group F |
Group F - would receive intravenous fentanyl 1.5 mcg/kg over 5 mins prior to induction |
| Comparator Agent |
Group N |
Group N (Control)- would receive intravenous normal saline over 5 mins prior to induction |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists physical status I or II
2. Age of 20–60 years
3. Either gender
4. Estimated operation time of ≤ 2 hours and anaesthesia time of ≤ 3 hours
5. Written informed consent to undergo the therapeutic regimen
|
|
| ExclusionCriteria |
| Details |
1. Renal dysfunction (serum creatinine > 1.2mg/dl)
2. Liver dysfunction (liver enzymes twice the normal range or higher)
3. History of chronic use of sedatives/ narcotics or analgesics/Beta blockers
4. BMI more than 30 kg/m2 or less than 15 kg/m2
5. Allergy to study medication
|
|
|
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 |
| EC 50 of propofol: The effective concentration of propofol will be recorded in all groups and will be used to calculate the EC50 |
EC 50 of propofol: The effective concentration of propofol will be recorded in all groups just before insertion of I-gel airway and will be used to calculate the EC50 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total Propofol requirement for induction in each group
|
After induction |
| Emergence time |
At the end of surgery to eye opening |
| Time to remove the airway device |
At the end of surgery |
| Degree of sedation by RASS scale |
Every 10 min from arrival in post anaesthesia care unit till discharge |
| Haemodynamic indices including Systolic Blood Pressure, Diastolic blood pressure and Mean Arterial Pressure, Heart Rate, Oxygen saturation |
From preoperative to Discharge every 10 minutes |
| Intraoperative MAC requirement |
Every 10 minutes intraoperatiely |
| Occurrence of any adverse events and duration of stay |
In Post anaesthesia care unit postoperatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/03/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
When propofol is used alone for induction, it produces minimal analgesia and large doses are required to induce general anaesthesia. Excessive depth of anaesthesia, and significant cardiovascular and pulmonary depression may result. To overcome these drawbacks, sedative and analgesics have been co-administered with propofol for anaesthesia induction. Dexmedetomidine has analgesic and sedative properties. Premedication of this drug can significantly reduce the requirement of propofol for induction of anaesthesia. Fentanyl reduces the median effective concentration of propofol for various noxious stimuli by 50 %. Fentanyl combined with propofol also has a depressive effect on haemodynamics. Also, a high target concentration of propofol itself (8 mg/ml) decreased MBP and increases frequency of apnea.
The present research is aimed to determine whether low dose Dexmedetomidine (0.5 mics/kg) is sufficient to decrease the propofol requirement for anaesthesia induction. We therefore intend to compare the median effective concentration (EC50 ; the concentration at which loss of consciousness occurred in 50 % of patients) of propofol for induction of anaesthesia comparing dexmedetomidine with fentanyl. We aim to determine the predicted EC50 of propofol for I-gel insertion(airway device) using TCI (Diprifusor) and will compare the propofol requirement for induction with fentanyl and low dose dexmedetomidine in patients undergoing elective ambulatory day care surgeries. We will be recording the BIS, haemodynamics, adverse events during induction and number of attempts of I-gel insertion, emergence time and duration of PACU stay. |