| CTRI Number |
CTRI/2023/07/055452 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on comparing drug response of dexmedetomidine and ketamine with fentanyl and morphine (drug name) for laparoscopic operation |
|
Scientific Title of Study
|
Opioid-Free versus Opioid-Based Anaesthesia for Elective Laparoscopic Surgery - A Double Blinded 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 |
P Ramyadevi |
| Designation |
1st Year Postgraduate Resident, Department of Anaesthesiology and Critical Care |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9698582635 |
| Fax |
|
| Email |
ramya10076@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Nagalakshmi |
| Designation |
Professor, Department of Anaesthesiology and Critical Care |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9894510137 |
| Fax |
|
| Email |
Vedha83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Ramyadevi |
| Designation |
1st Year Postgraduate Resident, Department of Anaesthesiology and Critical Care |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9698582635 |
| Fax |
|
| Email |
ramya10076@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital and Research Centre, No. 13-A, Pondy - Villupuram main road, Ariyur, Puducherry-605102. |
|
|
Primary Sponsor
|
| Name |
P Ramyadevi |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre, No. 13-A, Pondy - Villupuram Main Road, Ariyur, Pondicherry-605102. |
| Type of Sponsor |
Other [Self] |
|
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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 P Ramyadevi |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Department of Anaesthesiology, OT complex, Surgery division, room no. 5, Pondy - Villupuram main road, Ariyur, Pondicherry-605102.
Pondicherry
PONDICHERRY |
9698582635
ramya10076@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and ketamine for Elective laparoscopic surgery |
Patients will receive a loading dose of Dexmedetomidine 0.5 microgram per kg IV diluted to a total volume of 20ml and infused over 10 minutes with Loading dose of IV Paracetamol 15mg per kg with Bolus of Magnesium Sulphate 15mg per kg IV will be given during Induction.
Followed by a maintenance dose of Dexmedetomidine 0.3 microgram per kg per hour IV with Ketamine 0.1-0.2 mg per kg per hour IV Infusion after Intubation till the end of the surgery. |
| Comparator Agent |
Fentanyl and morphine for elective laparoscopic surgery |
Patients will receive a loading dose of Fentanyl 2 microgram per kg IV diluted to a total volume of 20ml and infused over 10 minutes during Induction. Followed by maintenance with bolus of morphine 0.1mg per kg IV after Intubation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI: 18.5 – 24.9
ASA (American Society of Anaesthesiologists) physical status of I and II
|
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating Women
ASA physical status of III and IV
Significant pain related neurological conditions
Patients currently taking opioid
Patients with allergies to study medication
Patient Refusal
H/O Drug Abuse, Psychiatric disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean systolic blood pressure between opioid free & opioid based anesthesia study groups for elective laparoscopic surgery. |
It will be monitored at baseline, before induction, post induction 3min, before intubation, post intubation 1 min, beginning of surgery, bef
ore abdominal insufflation, post abdominal insufflation 3min, 15 min,30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min & 150 min from induction , post deflation 3min, before extubation, after extubation 1min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the use of Postoperative Rescue Analgesia & the use of rescue for Postoperative Nausea & Vomiting. |
Postoperative pain will be assessed by visual analog scale score at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours. |
|
|
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 1 |
|
Date of First Enrollment (India)
|
28/07/2023 |
| 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
|
The Study is to Compare the
Efficacy of Opioid-Free and Opioid-Based Anaesthesia in terms of
Intraoperative Hemodynamic Stability and Post operative Analgesia in patients
undergoing Elective Laparoscopic Surgery under General Anaesthesia. The
hypothesis in this study is an opioid-free anaesthetic regimen
consisting of both dexmedetomidine and ketamine infusions, along with intravenous
(IV) paracetamol, and magnesium as a co-analgesic, is an effective
alternative anaesthetic technique, compared to the opioid-based anaesthetic regimen
regarding intraoperative hemodynamic stability, postoperative pain intensity,
and the incidence of side effects in the early post operative period.
|