| CTRI Number |
CTRI/2024/11/077196 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to know the effects of low dose of Dexmedetomidine (a calming drug) before surgery on the amount of Propofol (a sleep-inducing drug) needed to put patients to sleep during laparoscopic gallbladder removal surgery, while using a monitor to track their level of sleep |
|
Scientific Title of Study
|
The Effect of low-dose Dexmedetomidine premedication on induction dose of Propofol under BIS monitoring in laparoscopic cholecystectomy: a randomized controlled trial |
| 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 Sharon Chacko |
| Designation |
Postgraduate student |
| Affiliation |
Employees State Insurance - Post Graduate Institute of Medical Sciences and Research, Basaidarapur |
| Address |
Room no. 2207, Department of Anaesthesiology, 2nd floor OT complex, ESI Hospital Basaidarapur, Delhi-110015, India
New Delhi
DELHI
110015
India |
| Phone |
7389438655 |
| Fax |
|
| Email |
sharonchacko16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Nagpal |
| Designation |
Professor |
| Affiliation |
Employees State Insurance - Post Graduate Institute of Medical Sciences and Research, Basaidarapur |
| Address |
Department of Anaesthesiology, 2nd floor OT complex, ESI Hospital Basaidarapur, Delhi-110015, India
New Delhi
DELHI
110015
India |
| Phone |
9968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharon Chacko |
| Designation |
Postgraduate Student |
| Affiliation |
Employees State Insurance - Post Graduate Institute of Medical Sciences and Research, Basaidarapur |
| Address |
Room no. 2207, Department of Anaesthesiology, 2nd floor OT complex, ESI Hospital Basaidarapur, Delhi-110015, India
New Delhi
DELHI
110015
India |
| Phone |
7389438655 |
| Fax |
|
| Email |
sharonchacko16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Employees State Insurance- Post Graduate Institute of Medical Sciences and Research, Basaidarapur, New Delhi |
|
|
Primary Sponsor
|
| Name |
Employees State Insurance- Post Graduate Institute of Medical Sciences and Research, Basaidarapur |
| Address |
ESI-PGIMSR, Basaidarapur, New Delhi-110015 |
| 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 Sharon Chacko |
ESI-PGIMSR, Basaidarapur |
Surgery OT no. 6 and 7, Second floor OT, Department of Anaesthesiology,ESI-PGIMSR, Basaidarapur, New Delhi
New Delhi
DELHI |
7389438655
sharonchacko16@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ESI PGIMSR,Basaidarapur, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: K81||Cholecystitis, (3) ICD-10 Condition: K82||Other diseases of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal saline infusion |
Pateints in control group will receive IV infusion of Normal saline along with Fentanyl 2 mcg/cc in general anaesthesia |
| Intervention |
dexmedetomidine IV infusion |
Patients in test group will receive IV infusion of Dexmedetomidine 0.5 mcg/kg over 10 minutes as a premedication along with Fentanyl 2mcg/cc in general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and grade II
Laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Preoperative heart rate less than 60 beats per minute
Rhythm disturbances
Pregnancy
Allergic to Propofol or alpha 2 agonist |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The induction dose of propofol after low dose dexmedetomidine premedication |
At induction- 3 minutes after stopping dexmedetomidine infusion(at loss of verbal response) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The changes in BIS value at induction
|
5 min,10 min, at loss of consciousness,at intubation, post intubation at 3 min, 6 min, 9 min,12 min, 15 min
|
The hemodynamic response to intubation
|
At intubation, post intubation at 3 min, 6 min, 9 min,12 min, 15 min |
| Total intraoperative requirement of analgesics(Fentanyl) |
during intraoperative period |
| Post operative pain scores(NRS) |
Post operative period at 1, 2, 4, 6, 24 hours |
| Side effects, if any |
Intraoperatively and post operatively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
05/12/2024 |
| 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="1"
Months="0"
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
|
Aim of the study is to study the effect of premedication with low dose dexmedetomidine on the induction dose of propofol in elective laparoscopic cholecystectomy Eighty patients will be enrolled for this study after inclusion and exclusion criteria They will be randomly allocated into two groups Written informed consent will be taken from the patients Group D will receive 0.5 mcg/kg Dexmedetomidine IV along with 2 mcg/cc fentanyl IV followed by general anaesthesia and group C will receive normal saline infusion IV along with 2 mcg/cc fentanyl IV followed by general anaesthesia Heart rate, Mean Arterial Pressure, SpO2 and Bispectral Index will be noted at baseline , 5 and 10 minutes after stating dexmedetomidine infusion and at loss of verbal response, at intubation and post intubation at 3,6,9,12,15 minutes Anaesthesia will be induced in both groups with propofol till loss of verbal response and induction dose requirement of propofol in milligrams will be noted After completion of the surgical procedure and emergence from anaesthesia, pateint will be transferred to the post anesthesia recovery room Patient in both groups will be given IV Paracetamol six hourly for pain relief post surgery Patient will be assessed for pain using Numeric Pain Scale at 1,2,4,6 and 24 hours
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