CTRI Number |
CTRI/2019/11/022120 [Registered on: 22/11/2019] Trial Registered Prospectively |
Last Modified On: |
04/01/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Low-dose ketamine infusion during laparoscopic surgery for postoperative pain relief |
Scientific Title of Study
|
Intraoperative low dose ketamine infusion for postoperative pain relief in laparoscopic surgeries – A Prospective Randomised Double Blind Clinical Trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sujil Sudhersan |
Designation |
Post Graduate |
Affiliation |
Pondicherry Institute Of Medical Sciences |
Address |
Room no. 101, annex PG hostel, Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry
Pondicherry PONDICHERRY 605014 India |
Phone |
9629847356 |
Fax |
|
Email |
sujilegwu25@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mamie Zachariah |
Designation |
Professor in Anaesthesiology |
Affiliation |
Pondicherry Institute Of Medical Sciences |
Address |
Department of Anaesthesiology.
Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry
Pondicherry PONDICHERRY 605014 India |
Phone |
8344252595 |
Fax |
|
Email |
mamiezac@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mamie Zachariah |
Designation |
Professor in Anaesthesiology |
Affiliation |
Pondicherry Institute Of Medical Sciences |
Address |
Department of Anaesthesiology.
Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry
Pondicherry PONDICHERRY 605014 India |
Phone |
8344252595 |
Fax |
|
Email |
mamiezac@gmail.com |
|
Source of Monetary or Material Support
|
Pondicherry Institute Of Medical Sciences,
Ganapathychettikulam, Kalapet,
Pondicherry.
605014
|
|
Primary Sponsor
|
Name |
Pondicherry Institute Of Medical Sciences |
Address |
Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Puducherry -605014 |
Type of Sponsor |
Private medical college |
|
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 Sujil Sudhersan |
Pondicherry Institute Of Medical Sciences |
Department of Anaesthesiology,
Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry- 605014. Pondicherry PONDICHERRY |
9629847356
sujilegwu25@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
PIMS INSTITUTE 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 |
Comparator Agent |
0.9% of normal saline infusion in patients undergoing laparoscopic surgery for postoperative pain relief. |
0.9% of normal saline is given intravenously, a dose of 0.2mg/kg bolus before the first incision in surgery , followed by 0.1mg/kg/hour infusion till the end of surgery.Postoperatively the intensity of pain will be assessed.. |
Intervention |
Low dose ketamine infusion in patients undergoing laparoscopy surgery for postoperative pain relief. |
Ketamine is given intravenously, a dose of 0.2mg/kg bolus before the first incision in surgery , followed by 0.1mg/kg/hour infusion till the end of surgery.Postoperatively the intensity of pain will be assessed. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
General surgical patients aged 18 to 60 years belonging to American society of anaesthesia (ASA) I and II posted for laparoscopic surgeries. |
|
ExclusionCriteria |
Details |
1.Patients on chronic analgesic medication
2.Any known contraindication to the study drug
3.Patients with BMI> 30 kg/m2
4.Uncontrolled hypertension, raised intraocular pressure/glaucoma
5.Emergency surgery
6.Psychiatric patients
7.Pregnant women |
|
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 |
Determination of the efficacy of low dose Ketamine for postoperative pain relief in laparoscopic surgeries. |
6 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study and compare the frequency and amount of opioid requirement postoperatively between the two groups. |
6 hours |
To study and compare haemodynamic parameters intraoperatively between the two groups.
|
6 hours |
To study the occurrence of complications like hallucinations, sedation, vomiting, if any postoperatively.
|
6 hours |
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
29/11/2019 |
Date of Study Completion (India) |
04/03/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
1. Title of the dissertation: Intraoperative low dose ketamine infusion for postoperative pain relief in laparoscopic surgeries – A Prospective Randomised Double Blind Clinical Trial. 2. Introduction: Patients who undergo laparoscopic surgery experience less pain, less scarring, early ambulation and short recovery in comparison to the traditional open abdominal surgeries. However, there are undesirable side effects like postoperative pain, especially in the abdomen, back and shoulder tip due to stretching of intra-abdominal cavity leading to stimulation of sympathetic nerves and also because of hypercarbia and irritation of the phrenic nerve by residual carbon dioxide in the peritoneum. It is reported that 50% to 70% of laparoscopic surgery patients experience moderate to severe postoperative pain. N- Methyl D Aspartate receptor activation is considered to be one of the reasons for postoperative pain through both central and peripheral effects. Ketamine, a phencyclidine derivative is a non-competitive NMDA receptor antagonist that produces dissociative anaesthesia and ketamine induced analgesia. In most published studies, ketamine has been used in varying doses for postoperative pain relief in laparoscopic surgeries. However, it is seen that the psychosensory side effects of ketamine increases at doses above 0.3 mg/kg and low doses less than or equal to 0.1mg/kg were found to be prophylactically ineffective. Ketamine has been used both as a single preemptive bolus dose as well as repeated bolus doses throughout the period of surgery for postoperative pain relief. Literature search did not reveal many studies that had used ketamine as continuous infusion intraoperatively. So we aim to study a low dose ketamine bolus followed by infusion throughout the period of surgery assuming the infusion of ketamine would maintain a steady state plasma concentration and thus provide a better postoperative pain relief. In addition to analgesic benefits of ketamine, it has also been found to reduce opioid consumption postoperatively thus resulting in reduced incidence of sedation and nausea vomiting in these patients. 3. Research hypothesis: Intraoperative low dose ketamine bolus followed by infusion is effective in reducing postoperative pain in laparoscopic surgeries. 4. Study procedure: After obtaining ethical committee clearance of Pondicherry institute of medical sciences and informed as well as written consent ,52 patients aged 18-60 years belonging to ASA I or ASA II will be enrolled in the study .A thorough pre-anaesthetic check up including detailed history, general and systemic examination and review of routine investigations will be conducted a day before surgery. All the patients will be shown the Numerical Rating Scale (NRS) preoperatively and instructed about its use as a tool for measuring and grading postoperative pain after ensuring nil per oral for a period of 8 hours. The selected patients will be split into two groups. One group will receive 0.2mg / kg ketamine bolus and then 0.1mg / kg / hour ketamine infusion until end of surgery. The other group will receive a similar amount of 0.9% NaCl. In the Operation Theater blood pressure, heart rate and oxygen levels will be monitored and recorded. An I V cannula will be secured for injecting medication. A face mask will be placed for the oxygen supply. After that they will be anaesthetized. Once unconscious, a tube is placed through the mouth . The air entry will be checked. Subsequently, the drug prepared will be provided under supervision until the end of surgery. After surgery all the anaesthetic agents will be cut, oxygen will be given and the tube will be removed. After regain of consciousness, patients will be transferred to the recovery room , they will be questioned if there is pain or any side effects of the study drug, and will be evaluated according to the pain criteria explained before the day of surgery. If there is pain after surgery, analgesics will be given. 5. Parameters to be studied a) Postoperative pain b) Haemodynamic parameters c) Postoperative opioid consumption d) Grade of sedation e) Record of adverse effects if any. 6. Expected Outcome: Determination of the efficacy of low dose Ketamine for postoperative pain relief in laparoscopic surgeries. |