| CTRI Number |
CTRI/2024/03/063426 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Intravenous Ketamine and Magnesium Sulphate in reducing post operative pain and to check inflammatory response in lower belly surgery. |
|
Scientific Title of Study
|
Comparative evaluation of Intravenous Ketamine and Magnesium Sulphate for Attenuation of post operative pain and stress response in lower abdominal surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shanu Singh |
| Designation |
PG Junior Resident anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital Faridkot |
| Address |
Department of anaesthesia
Guru Gobind Singh Medical College and Hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9045181650 |
| Fax |
|
| Email |
shanudoctor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Haramritpal Kaur |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and hospital |
| Address |
Department of anaesthesia
Guru Gobind Singh Medical College and Hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amritk_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Haramritpal Kaur |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of anaesthesia
Guru Gobind Singh Medical College And Hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amrit_dr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
Guru Gobind Singh Medical College and Hospital Faridkot
Punjab |
|
|
Primary Sponsor
|
| Name |
Haramritpal Kaur |
| Address |
Department of anesthesia
Guru Gobind Singh Medical College and Hospital Faridkot Punjab |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR SARVJEET KAUR |
PROFESSOR AND HEAD DEPARTMENT OF ANAESTHESIA GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL FARIDKOT PUNJAB |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shanu singh |
Guru Gobind Singh Medical College and Hospital |
Department of anaesthesia
Guru Gobind Singh Medical College and Hospital
Faridkot
PUNJAB |
9045181650
shanudoctor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF GGSMCH FARIDKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine |
To assess the effect of ketamine to reduce post operative pain and stress response. Drug being given during intraoperative time. Patient will receive intravenous ketamine bolus of 0.2 mg/kg after induction of anaesthesia followed by infusion of 0.05 mg/kg/h intraoperatively till end of surgery. |
| Comparator Agent |
Magnesium sulphate |
To assess the effect of magnesium sulphate to reduce post operative pain and stress response. Drug being given during intraoperative time. Patient will receive intravenous magnesium sulphate bolus of 50mg/kg after the induction of anaesthesia followed by infusion of 10 mg/kg/h intraoperatively till end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients from 18-65 years of age of either gender
ASA Grade I and II
Patients posted for elective lower abdominal surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
History of anaphylaxis or allergy to the study drugs
Patients having hepatic renal and cardiovascular dysfunction
Patient having any septic infections
History of chronic pain
Psychiatric disorders or drug abuse
Chronic use of opioids or alcohol
BMI more than equal to 30 kg per m square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of intravenous ketamine and magnesium sulphate on post operative analgesic consumption after lower abdominal surgery |
Outcome will be assessed at the end of one and half year of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of intravenous ketamine and magnesium sulphate on stress response |
Outcome will be assessed at the end of one and half year of study |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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
|
Introduction: Pain is a common phenomenon in postoperative period. Adequate post operative pain management after major surgeries is important for earlier mobilization, to reduce length of hospital stay and for prevention of chronic pain syndrome.
Aims and Objectives : We aim to evaluate and compare the effect of intravenous ketamine and magnesium sulphate on post operative analgesic consumption after lower abdominal surgery as primary outcome and stress response as secondary outcome. Material and Methods: The study will be conducted in comparative manner in GGS Medical College and Hospital, Faridkot on 60 patients belonging to American Society of Anaesthesiologists (ASA) Grade I / II; aged 18-65 years; scheduled for lower abdominal surgery under general anaesthesia . Patients will be allocated into three groups of 30 each. • Group K - These patients will receive intravenous ketamine: bolus of 0.2mg/kg after induction of anaesthesia followed by infusion of 0.05mg/kg/h till end of surgery. • Group M - These patients will receive intravenous magnesium sulphate: bolus of 50 mg/kg after induction of anaesthesia followed by 10mg/kg/h till end of surgery. Intraoperative opioid consumption, total analgesic consumption in 24 hour post operatively, pain score, CRP levels preoperative and postoperative, emergence time and any side effects of the drugs will be assessed. The data will then be statistically analysed. |