| CTRI Number |
CTRI/2020/06/025756 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
“COMPARISON OF THE EFFECT OF INTRAVENOUS LIGNOCAINE VERSUS KETAMINE IN LAPAROSCOPIC SURGERIES FOR POST OPERATIVE PAIN RELEIF AND HEAMODYNAMIC STABILITY DURING SURGERY†|
|
Scientific Title of Study
|
“COMPARISON OF THE EFFICACY OF INTRAVENOUS INFUSION OF LIGNOCAINE VERSUS KETAMINE IN LAPAROSCOPIC SURGERIES; A RANDOMISED, CONTROLLED STUDY.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sosa Saji Paul |
| Designation |
Resident |
| Affiliation |
Bharati Vidyapeeth University Medical College, Hospital and Research centre |
| Address |
PG girls hostel, Bharati Vidyapeeth Medical College and Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8669049664 |
| Fax |
|
| Email |
sosa.spaul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varshali Miral Keniya |
| Designation |
Associate Proffesor |
| Affiliation |
Bharati Vidyapeeth University Medical College, Hospital and Research centre |
| Address |
Department of Anaesthesiology, Bharati Vidyapeeth Medical College and Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9881419089 |
| Fax |
|
| Email |
varshkeniya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sosa Saji Paul |
| Designation |
Resident |
| Affiliation |
Bharati Vidyapeeth University Medical College, Hospital and Research centre |
| Address |
PG girls hostel, Bharati Vidyapeeth Medical College and Hospital, Dhankawadi, Pune
MAHARASHTRA
411043
India |
| Phone |
8669049664 |
| Fax |
|
| Email |
sosa.spaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sosa Paul
PG girls hostel
Bharati Vidyapeeth
Dhankawadi
Pune
411043 |
|
|
Primary Sponsor
|
| Name |
Sosa Saji Paul |
| Address |
New PG girls hostel, Bharati Vidyapeeth Campus,Dhankawadi,Pune |
| 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 Sosa Paul |
Bharati Vidyapeeth Medical college and research centre |
Department of Anaesthesiology, Bharati Medical College, Hospital and Research centre
Dhankawadi, 411043
Pune
MAHARASHTRA |
8669049664
sosa.spaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravenous ketamine |
Intravenous bolus dose of 0.3 mg/kg at induction followed by 0.2mg/kg/hr i.v infusion until ports are out |
| Intervention |
intravenous loxicard |
Bolus dose of loxicard 1.5mg/kg i.v at induction followed by infusion of 1.5mg/kg/hr after intubation until the laparoscopic surgical ports are out. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grades 1 & 2
2. patients undergoing elective laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Known allergy to local anaesthetic
3. use of opiod analgesics in the past 24 hours
4. presence of renal/liver disease
5. patients with known seizure disorders/psychiatricdisorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maintanence of intra -operative heamodynamic stability |
Duration of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased postoperative analgesic requirement |
Immediate 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/06/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This trial is a comparitive study of the post operative analgesic requirement and intraoperative heamodynamic stability when infused with ketamine vs kignocaine intraoperatively, in sub anaesthetic doses in a patient undergoing elective laparoscopic surgeries under general anaesthesia. From our study, it can be concluded that ketamine provides better post-operative analgesia and intraoperative hemodynamic stability in comparison with lignocaine. |