| CTRI Number |
CTRI/2023/12/060691 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of effects of different amounts of drug called Dexmedetomidine which helps in reducing stress response like increasing blood pressure, heart rate, coughing etc when patients get a breathing tube removed after having laparoscopic surgery to remove their gallbladder. |
|
Scientific Title of Study
|
A comparative study of two infusion doses of Dexmedetomidine for alleviating stress response to tracheal extubation in patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Janvi Vikram Thakkar |
| Designation |
DNB Resident |
| Affiliation |
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital |
| Address |
PAC Clinic Room No 1,
1st Floor General OT,
Anesthesia department,
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital,
Irba, Ranchi
Ranchi
JHARKHAND
835217
India |
| Phone |
8849851760 |
| Fax |
|
| Email |
janvithakkar1989@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Naseem Akhtar |
| Designation |
Had Of The Anesthesia Department and Guide |
| Affiliation |
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital |
| Address |
PAC Clinic Room No 1,
1st Floor General OT,
Anesthesia department,
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital,
Irba, Ranchi
Ranchi
JHARKHAND
835217
India |
| Phone |
9955577739 |
| Fax |
|
| Email |
Naseem.Akhtar@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Naseem Akhtar |
| Designation |
Had Of The Anesthesia Department and Guide |
| Affiliation |
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital |
| Address |
PAC Clinic Room No 1,
1st Floor General OT,
Anesthesia department,
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital,
Irba, Ranchi
Ranchi
JHARKHAND
835217
India |
| Phone |
9955577739 |
| Fax |
|
| Email |
Naseem.Akhtar@medanta.org |
|
|
Source of Monetary or Material Support
|
| Medanta Abdur Razzaque Ansari Memorial Weavers Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Janvi Vikram Thakkar |
| Address |
PAC Clinic Room No 1,
1st Floor General OT,
Anesthesia department,
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital,
Irba, Ranchi,
Jharkhand-835217 |
| 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 |
| Dr Janvi Vikram Thakkar |
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital |
PAC Clinic Room No 1,
1st Floor General OT,
Anesthesia department,
Medanta Abdur Razzaque Ansari Memorial Weavers Hospital,
Irba, Ranchi,
Jharkhand-835217
Ranchi
JHARKHAND |
8849851760
janvithakkar1989@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG CURIE ABDUR RAZZAQUE ANSARI CANCER INSTITUTE |
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 |
-Loading dose of Dexmedetomidine 0.5 μg per kg diluted to 10ml ( Duration : over period of 10 mins before starting of the infusion)
-Dexmedetomidine 0.3 μg per kg per hour IV infusion ( Duration : until extubation ) |
| Comparator Agent |
Dexmedetomidine |
-Loading dose of Dexmedetomidine 0.5 μg per kg diluted to 10ml ( Duration : over period of 10 mins before starting of the infusion)
-Dexmedetomidine 0.5 μg per kg per hour IV infusion ( Duration : until extubation ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I & II patients undergoing Laparoscopic Cholecystectomy |
|
| ExclusionCriteria |
| Details |
- Those on β-blockers, Digoxin, Alpha 2-adrenergic agonists or psychotropic medications
- Patients with Heart Rate below 60 per min or Blood Pressure less than 100 mmHg systolic and less than 60 mmHg diastolic
- Patients with a history of allergic reactions to drug used in study.
- Patients who required postoperative mechanical ventilation
- Pregnant or nursing woman
- Morbidly obese patients
- ASA Grade III & IV patients
- Anticipated difficult intubation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Haemodynamic changes during tracheal extubation
- Airway response using 5 point scale during tracheal extubation |
During extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Time taken for emergence & tracheal extubation
- Evaluation for presence of complications such as laryngospasm, bronchospasm, delayed recovery, respiratory depression, & bradycardia |
During extubation |
|
|
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 |
|
Date of First Enrollment (India)
|
29/12/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is a prospective randomized double blinded study designed to compare two
infusion doses of Dexmedetomidine for evaluating haemodynamic response and
airway response during tracheal extubation.
Total of
60 patients undergoing laparoscopic cholecystectomy who fulfil the inclusion
criteria and who have given written informed consent will be randomly assigned
into 2 groups.
Each
group of 30 patients will receive different infusion doses of Dexmedetomidine. - Group
D0.3 will receive Inj. Dexmedetomidine 0.3 μg/kg/hour IV infusion. - Group
D0.5 will receive Inj. Dexmedetomidine 0.5 μg/kg/hour IV infusion.
Effect
of both the doses of the drug will be monitored in terms of sympathetic
responses during tracheal extubation like heart rate and mean arterial pressure.
Laryngeal reflexes and cough response will be monitored using 5-point scale.
This
study aims to optimise the extubation process and enhance patient safety.
Overall, this study holds significant potential to improve the management of
endotracheal extubation, which is a critical step in the postoperative care of
patients. By minimizing the cardiovascular and airway responses associated with
extubation, Dexmedetomidine could contribute to enhanced patient outcomes and
reduce the risk of life-threatening complications. |