| CTRI Number |
CTRI/2024/05/066934 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the duration of postoperative analgesia in patients undergoing Laparoscopic cholecystectomy using Dexmedetomidine and Magnesium sulfate as adjuvants to Bupivacaine in Transversus Abdominis Plane block. |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Magnesium sulphate as adjuvant to Bupivacaine in ultrasound guided right oblique subcostal Transversus Abdominis Plane block for post operative analgesia 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 Mohammed Samjad E U |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care. VMMC and Safdarjung Hospital.Ansari nagar East. New delhi
New Delhi
DELHI
110029
India |
| Phone |
9645848908 |
| Fax |
|
| Email |
samjad.sanju969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Chaudhary |
| Designation |
Director professor and Head of Department |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia & Intensive care. Vardhman Mahavir Medical College and Safdarjung Hospital. New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9999051546 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Chaudhary |
| Designation |
Director professor and Head of Department |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care. VMMC and Safdarjung hospital.New delhi
New Delhi
DELHI
110029
India |
| Phone |
9999051546 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital. Ansari nagar east.New Delhi. India. Pin- 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and intensive care.
VMMC and Safdarjung hospital
New Delhi 110029 |
| 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 Sujata Chaudhary |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of anaesthesia and intensive care.
Vardhman Mahavir medical college and Safdarjung hospital. New Delhi 110029
New Delhi
DELHI |
9999051546
sujatac462@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC AND SAFDARJUNG HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided right oblique subcostal transversus abdominis plane block |
18 mL 0.25% BUPIVACAINE + 0.5mcg/kg DEXMEDETOMIDINE in 2 ml Normal saline
TOTAL DRUG VOLUME - 20 ml |
| Intervention |
Ultrasound guided right oblique subcostal transversus abdominis plane block |
18 ml 0.25% BUPIVACAINE + 1.5 ml ( 150 mg) magnesium sulphate + 0.5 ml normal saline.
Total drug volume - 20 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All Patients belonging to American Society of Anaesthesiologists(ASA) grade I and II and aged between 18–65 years of both genders, undergoing elective laparoscopic cholecystectomy with duration of surgery less than 2 hours are included in the stud |
|
| ExclusionCriteria |
| Details |
1. History of allergy to drugs used in the study.
2. Infection or inflammation at the site of block application
3. Pregnant women
4. Those with a BMI of 30 and above.
5. Patients who have cognitive disability or unable to understand the VAS score. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of post operative analgesia (Time to first rescue analgesia as per Visual Analogue Scale for pain) using Magnesium sulphate and Dexmedetomidine as adjuvant to Bupivacaine in ultrasound guided right oblique subcostal Transversus Abdominis Plane Block in patients undergoing Laparoscopic Cholecystectomy. |
Post operatively at 0 hour , 1 hour, 2 hours, 6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the total amount of analgesics consumed in the initial 24 hours .
2. To evaluate changes in the hemodynamic parameters( Blood pressure and Heart rate)
during intraoperative period and postoperative period over 24 hours.
3. To assess post operative sedation using Ramsay Sedation Score. |
Intra operatively and post operative period |
|
|
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)
|
16/05/2024 |
| 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="6"
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
|
In this study we plan to compare Dexmedetomidine and Magnesium sulphate as adjuvant to Bupivacaine in ultrasound guided right oblique subcostal Transversus Abdominis Plane block for post operative analgesia in patients undergoing Laparoscopic cholecystectomy. Patients will be randomly allocated into 2 groups of 30 patients each. Group BM will receive magnesium sulphate as adjuvant to BUPIVACAINE whereas group BD will receive DEXMEDETOMIDINE as adjuvant with BUPIVACAINE.1. Each patient will be assessed for pain at rest with VAS Scoring system at 0, 1hour, 2hours, 6hours , 12hours and 24hours postoperatively. 2. Duration of analgesia – time duration between administration of block to the administration of first rescue analgesia(Injection Diclofenac 75mg IV) to the patient will be noted. (Rescue analgesia is administered when the patient complaints of breakthrough pain or on assessment VAS score is more than 3). 3. The total amount of rescue analgesics consumed in the initial 24 hours is calculated. 4. Evaluation of changes in the hemodynamic parameters (SBP/DBP/MAP and heart rate) in intraoperative period and 24 hours post operatively. 5. Assessment of post operative sedation using Ramsay sedation score at 0hr,1hour,2hours,6hours,12hours,24hours post operatively. |