| CTRI Number |
CTRI/2022/11/047740 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
24/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pain management with three oral drugs in patients undergoing robotic surgeries |
|
Scientific Title of Study
|
"A comparison of analgesic efficacy between oral pregabalin, gabapentin and melatonin as non-opioid anaesthesia for robotic assisted laparoscopic surgeries: A prospective randomised double blinded clinical study." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTmonica daisy |
| Designation |
assistant professor |
| Affiliation |
saveetha medical college |
| Address |
Department of anaesthesia ,saveetha medical college
162, Poonamallee high road, velappanchavadi, Chennai-600077
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9842883777 |
| Fax |
|
| Email |
monicalinsy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTmonica daisy |
| Designation |
assistant professor |
| Affiliation |
saveetha medical college |
| Address |
Department of anaesthesia ,
saveetha medical college,
162, Poonamallee high road, velappanchavadi, Chennai-600077
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9842883777 |
| Fax |
|
| Email |
monicalinsy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTmonica daisy |
| Designation |
assistant professor |
| Affiliation |
saveetha medical college |
| Address |
department of anaesthesia ,
Saveetha medical college
162, Poonamallee high road, velappanchavadi, Chennai-600077
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9842883777 |
| Fax |
|
| Email |
monicalinsy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha medical college, 162, Poonamallee high road, velappanchavadi, Chennai-600077 |
| 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 |
| drtmonica daisy |
saveetha medical collge |
Department of anaesthesia
Kancheepuram
TAMIL NADU |
9842883777
monicalinsy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethics committee |
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 |
| Intervention |
a prospective study |
a protective randomised double blinded study |
| Comparator Agent |
gabapentin |
Gabapentin 900mg per oral given one hour prior to surgery |
| Comparator Agent |
melatonin |
Tab melatonin 6mg given orally one hour prior to surgery |
| Comparator Agent |
pregabalin |
Pregabalin 150 mg per oral one hour prior to surgery is given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
elective surgical procedures
ASA PS 1 & 2
BMI <35 kg/m2 |
|
| ExclusionCriteria |
| Details |
emergency surgical procedures
patients with history of chronic pain syndrome
patients with hepatic, neurological, renal, respiratory and cardiac pathologies
allergic to gabapentin, pregabalin,melatonin
difficult airway
history of seizure disorder
asa ps >3
electrolyte abnormalities
patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative analgesia |
1hour, 2 hour , 4 hour , 8 hour , 12 hour ,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
preoperative hemodynamics
preoperative sedation score
rescue analgesia requirement
perioperative anxiety score |
30mins, 1 hour , 4 hour , 12 hour, 24 hour |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
preemptive use of oral pregabalin, gabapentin or melatonin for postoperative pain control, anxiety and hemodynamics in such patients has been suggested in standardised research. our study compares oral pregabalin, gabapentin,melatonin as presumptive analgesia at a dose of 150 mg, 900 mg and 6 mg respectively. |