| CTRI Number |
CTRI/2022/10/046735 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
21/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of two drugs, dexmedetomidine , a drug used in treatment of raised blood pressure and paracetamol , a drug used for pain relief in patients undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
A comparative study of the efficacy of intravenous paracetamol and dexmedetomidine alone and in combination on peri-operative haemodynamics and post-operative analgesia for patients undergoing laparoscopic cholecystectomy under general anesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gadde Venkata Harshitha |
| Designation |
Junior resident |
| Affiliation |
Gajra raja medical college |
| Address |
Department of Anaesthesiology, G.R.Medical college ,Gwalior
Gwalior, Madhya pradesh
474002
India
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
7997899898 |
| Fax |
|
| Email |
harshi.gadde333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Agrawal |
| Designation |
Assosciate Professor |
| Affiliation |
Gajra raja medical college |
| Address |
Department of Anesthesiology, G.R.Medical college, Gwalior,Madhya pradesh
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gadde venkata Harshitha |
| Designation |
junior resident |
| Affiliation |
Gajra raja medical college |
| Address |
Department of Anesthesiology, G.R.Medical college , Gwalior, Madya pradesh
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
7997899898 |
| Fax |
|
| Email |
harshi.gadde333@gamil.com |
|
|
Source of Monetary or Material Support
|
| Patients undergoing laparoscopic cholecystectomy surgeries under general anesthesia at G.R.Medical College and J.A.Group of hospitals |
|
|
Primary Sponsor
|
| Name |
DrGadde Venkata Harshitha |
| Address |
Department of Anesthesiology, G.R.Medical college, Gwalior |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Jitendra Agrawal |
Assosciate Professor, Department of Anesthesiology, G.R.Medical College, Gwalior |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gadde venkata Harshitha |
J.A group of hospitals, Gajra raja medical college |
Department of Anesthesiology, Gajra raja medical college, Gwalior
Gwalior
MADHYA PRADESH |
7997899898
harshi.gadde333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Gajra raja medical college, Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paracetamol and dexmedetomidine |
Loading dose of paracetamol 1gm in 100ml over 15mins before induction of anesthesia and dexmedetomidine 0.2microgram/kg/hr by continuous infusion during introperative period. |
| Intervention |
Dexmedetomidine |
Loading dose 0.5microgram/kg over 15mins before induction of anesthesia and 0.2microgram/kg/hr by continuous infusion during intraoperative persiod |
| Comparator Agent |
Paracetamol |
loading dose 1gm in 100ml over 15mins before induction of anesthesia and 0.2ml/kg/hr 0.9% Normal saline as continuous infusion during intraoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Consent to participate in the study
2.Patients scheduled for laparoscopic cholecystectomy
3.American society of anaesthesiology grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Uncooperative patient/ not able to understand pain assessment test
2.Pregnant and lactating women
3.History of any significant pulmonary, cardiovascular, neurological, hepatorenal, pshyciatric or metabolic disease.
4.Bleeding diathesis.
5.History of previous allergy to paracetamol |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine and Paracetamol combination is more effective in maintaining the hemodynamic responses and intraoperative hemodynamic variables in laparoscopic cholecystectomy surgery than individual drugs. |
baseline, 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain is minimal with combination group |
24hours |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 4 |
|
Date of First Enrollment (India)
|
22/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/10/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is prospective, double blinded, randomised controlled study comparing the efficacy of dexmedetomidine and paracetamol alone and in combination on perioperative haemodynamics and postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anesthesia. Laparoscopic surgery a challenge to the anaesthesiologist as it is accompanied with haemodynamic instability and postoperative pain, in this study we are looking for better drug or combination of drugs for attenuating these complications. |