| CTRI Number |
CTRI/2025/01/079043 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TO STUDY THE EFFECT OF PAIN USING KETAMINE IN PATIENTS UNDERGOING ELECTIVE SURGERIES. |
|
Scientific Title of Study
|
PREEMPTIVE ANALGESIA USING LOW DOSE INTRAVENOUS KETAMINE FOR POST OPERATIVE PAIN IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nazia Akhtar Barbhuiya |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College And Hospital , Guwahati |
| Address |
Department of Anaesthesiology and Critical Care , Gauhati Medical College And Hospital , Guwahati, Bhangagarh, Kamrup Metro ,Guwahati, PIN - 781032 , Assam , India
Kamrup
ASSAM
781032
India |
| Phone |
8638606889 |
| Fax |
|
| Email |
naziabarbhuiya4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aldiona Shanpru Bhattacharyya |
| Designation |
Associate Professor , Department of Anaesthesiology and Critical Care, |
| Affiliation |
Gauhati Medical College and Hospital , Guwahati |
| Address |
Department of Anaesthesiology and Critical Care , Gauhati Medical College And Hospital , Guwahati, Bhangagarh, Kamrup Metro ,Guwahati, PIN - 781032 , Assam , India
Kamrup
ASSAM
781032
India |
| Phone |
9101813237 |
| Fax |
|
| Email |
aldiona.shanpru1958@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazia Akhtar Barbhuiya |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College And Hospital , Guwahati |
| Address |
Department of Anaesthesiology and Critical Care , Gauhati Medical College And Hospital , Guwahati, Bhangagarh, Kamrup Metro ,Guwahati, PIN - 781032 , Assam , India
Kamrup
ASSAM
781032
India |
| Phone |
8638606889 |
| Fax |
|
| Email |
naziabarbhuiya4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Guwahati
Assam, India
PIN 781032 |
|
|
Primary Sponsor
|
| Name |
Dr Nazia Akhtar Barbhuiya |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College And Hospital, Bhangagarh, Guwahati, Assam PIN 781032 |
| 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 Nazia Akhtar Barbhuiya |
Gauhati Medical College And Hospital, Guwahati |
Department of Anaesthesiology and Critical Care, Gauhati Medical College And Hospital, Bhangagarh, Guwahati PIN 781032 , kamrup , assam
Kamrup
ASSAM |
8638606889
naziabarbhuiya4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethic Committee of Gauhati Medical College And Hospital |
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 |
Injection Ketamine |
In one group intravenous ketamine 0.5mg/kg given after after induction of general anesthesia and 10 minutes before surgical incision |
| Comparator Agent |
Normal Saline |
In another group intravenous normal saline given after induction of general anesthesia and 10 minutes before surgical incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age : 18-60years.
2.ASA grade 1 and 2.
3.Patient posted for elective laparoscopic cholecystectomy.
4.Patients giving consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give informed and written consent.
2. BMI more than 40.
3. Surgery converted to open cholecystectomy.
4. Chronic pain syndrome.
5. Drugs , opiods , or any substance abuse.
6. History of allergy to ketamine.
7. Raised intra-cranial pressure.
8. Known case of hypertension , hyperthyroidism , psychiatric disorder.
9. History of seizure or taking anticonvulsant medication.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of preemptive use of small dose intravenous ketamine on post operative pain using Numeric Rating Scale Score on patients undergoing elective laparoscopic cholecystectomy |
To evaluate the efficacy of preemptive use of small dose intravenous ketamine on post operative pain using Numeric Rating Scale Score at time 0(immediately after arousal), 6,12 and 24 hours on patients undergoing elective laparoscopic cholecystectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate time interval for first request of analgesia.
2.To evaluate post operative total opioid consumption in first 24 hours.
3. To evaluate the incidence of post operative side effects like nausea , vomiting, delirium and hallucination.
|
To evaluate time interval for first request of analgesia, post operative total opioid consumption in first 24 hours and any post operative complications |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
30/01/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
The most important factor related to patient discomfort after surgery is pain. The concept of Pre-emptive analgesia is to reduce central sensitization that arises from noxious input during the perioperative period and also the magnitude and duration of post operative pain. Pre-emptive analgesia gives rise to a subsiding pain pattern, a decrease in analgesic requirement and a decline in morbidity, promoting wellness and shortening the length of hospital stay. Laparoscopic cholesystectomy as a minimally invasive surgery has become extremely common in recent decades. Despite the fact that Laparoscopic cholecystectomy is associated with less pain and disability , nonetheless as many as 76.7% patients experience moderate to severe pain ( NRS 4-10) within first 24 hours Although many drugs have demonstrated the evidence of preemptive analgesic benefit. Ketamine , an NMDA receptor antagonist have received greatest attention because NMDA receptors have effectiveness to intercept intra as well as post operative pain and also had role in central sensitization and neural modulation. |