| CTRI Number |
CTRI/2024/07/071480 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of non opioid drugs and opioid drug for pain relief after laparoscopic surgeries. |
|
Scientific Title of Study
|
A comparative study of opioid free anaesthesia versus opioid based anaesthesia for post operative pain relief in patients undergoing laparoscopic surgeries- A double blinded randomized controlled trial. |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha ann johnson |
| Designation |
Post graduate |
| Affiliation |
Sri balaji vidyapeeth university |
| Address |
Department of anaesthesia,
shri sathya sai medical college and research institute.
Thiruporur, guduvancherry main road,chengalpet taluk, kancheepuram district, Tamilnadu
603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9080119326 |
| Fax |
|
| Email |
sonyann1983@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dilip Kumar. G |
| Designation |
Professor , Head of the department |
| Affiliation |
Sri balaji vidyapeeth university |
| Address |
Department of anaesthesia,
Shri sathya sai medical college and research institute.
thiruporur, guduvancherry main road
chengalpet taluk, kancheepuram district, Tamilnadu
603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9094940243 |
| Fax |
|
| Email |
dilipko@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Ann Johnson |
| Designation |
Post graduate |
| Affiliation |
Sri balaji vidyapeeth university |
| Address |
Department of anaesthesia,
Shri sathya sai medical college and research institute.
thiruporur, guduvancherry main road
chengalpet taluk, kancheepuram district, Tamilnadu
603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9080119326 |
| Fax |
|
| Email |
sonyann1983@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Shri Sathya Sai Medical College and Research Institute.
Thiruporur, guduvancherry main road, Chengalpet taluk,kancheepuram district, Tamilnadu
603108
|
|
|
Primary Sponsor
|
| Name |
Dr Sneha Ann Johnson |
| Address |
Department of Anaesthesia,
Shri sathya sai medical college and research institute.
Thiruporur, guduvancherry main road, chengalpet taluk,kancheepuram district, Tamilnadu,
603108
|
| 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 Sneha Ann Johnson |
Shri sathya sai medical college and research institute |
Department of anaesthesia,
2nd floor anaesthesia OT complex.
Thiruporur, guduvancherry main road
chengalpet taluk,ammapettai kancheepuram district, Tamilnadu.
603108
Kancheepuram
TAMIL NADU |
09080119326
sonyann1983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Opioid based drugs in anaesthesia (Group O) |
loading dose:
IV. Fentanyl 2mcg/kg in 100ml NS- 10 min before induction of anaesthesia,
Infusion Fentanyl 0.5mcg/kg/hr
|
| Intervention |
Opioid free drugs in anaesthesia (Group F) |
loading dosage :
IV. Dexmedetomidine 1mcg/kg,
IV. Ketamine 0.2mg/kg,
IV. lignocaine 2mg/kg, in 100ml NS – 10 min before induction of anaesthesia.
Infusion Dexmedetomidine 0.5mcg/kg/hr
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient assessed and physically fit under the ASA category I and II |
|
| ExclusionCriteria |
| Details |
body mass index of more than 35 kg/m2
Patients with known allergy to drug used in this study.
Patients with renal and liver insufficiency, hyperthyroidism, hormonal therapy.
Patient with psychiatric illness
Patient with chronic pain conditions.
Patient having cardiovascular diseases.
Patient who are not willing for the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue score
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess the quality and duration of the postoperative analgesia by using Visual Analogue score
To assess the amount of total analgesics consumed in initial 24 hours.
To assess the changes in the intraoperative and postoperative hemodynamic parameters.
|
hemodynamic parameters - intraoperative , postoperative |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 11-01-2027 and end date provided 29-12-2033?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
After getting approval from the ethics committee, patients will be randomly allocated into 2 groups via computer generated group of numbers.
Group F - OPIOID FREE GROUP : will be receiving loading dose of IV. Dexmedetomidine 1mcg/ kg, IV. Lignocaine 2mg/kg in 100 ml normal saline in first 10 min before the induction of anesthesia and then followed by infusion IV. Dexmedetomidine 0.5mcg/kg/hr. till the end of the surgery.
Group O - OPIOID GROUP: will be receiving IV, Fentanyl 2mcg/kg in the first 10 min before induction of the anesthesia and then followed by infusion IV. Fentanyl 0.5mcg/kg/hr. till the end of the surgery.
After the pre oxygenation with 100% oxygen. induction achieved with Inj. Propofol 2.5mg/kg in both the groups, endotracheal intubation would be facilitated by INJ. Succinylcholine 1.5mg/kg and the airway will be secured with appropriately sized tube.
The lungs will be ventilated using 50% oxygen and nitrous oxide with depth of anesthesia maintained by isoflurane. the muscle relaxation will be maintained with Inj. Vecuronium 0.1mg/kg followed by top up doses.
Any event of bradycardia will be treated with Inj. Atropine 0.02mg/kg. and event of hypotension will be managed with Inj. Ephedrine 6mg bolus.
In both cases intrabdominal pressures will be maintained within 12-15mmhg. end tidal carbon dioxide monitoring will be maintained less than 35 mmhg. Both groups are given non opioid analgesic Inj. Paracetamol 1 gm which would be given at the end of the surgery.
Inj. Neostigmine+ Inj. glycopyrolate will be used as reversal and then patient shifted to post operative unit care.
post extubation monitoring will be maintained at 0,4,12,24 hrs. post operative vitals, pain score, will be assessed in all the patients.
the time for the first analgesic request and the total analgesic consumption will be then calculated and documented on the data collection Performa. |