CTRI Number |
CTRI/2021/02/030967 [Registered on: 03/02/2021] Trial Registered Prospectively |
Last Modified On: |
02/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two regimens of total intravenous anaesthesia for time to recovery from anaesthesia. |
Scientific Title of Study
|
Randomised Controlled Trial to compare time to post operative recovery after opioid free total intravenous anaesthesia using propofol with ketamine or dexmedetomidine in patients undergoing elective surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sahir Alam |
Designation |
PG Student |
Affiliation |
lady hardinge medical college |
Address |
DEPARTMENT OF ANAESTHESIOLOGY
LADY HARDINGE MEDICAL COLLEGE
SHAHEED BHAGAT SINGH MARG NEW DELHI
Central DELHI 110001 India |
Phone |
8287409037 |
Fax |
|
Email |
sahir103@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Nishant Kumar |
Designation |
Professor |
Affiliation |
LHMC |
Address |
Dept. of Anaesthesiology
Shaheed Bhagat Singh Marg
Central DELHI 110001 India |
Phone |
9811934659 |
Fax |
|
Email |
kumarnishant@yahoo.co.uk |
|
Details of Contact Person Public Query
|
Name |
Nishant Kumar |
Designation |
Professor |
Affiliation |
LHMC |
Address |
Dept. of Anaesthesiology
Shaheed Bhagat Singh Marg
North West DELHI 110001 India |
Phone |
9811934659 |
Fax |
|
Email |
kumarnishant@yahoo.co.uk |
|
Source of Monetary or Material Support
|
LADY HARDINGE MEDICAL COLLEGE NEW DELHI |
|
Primary Sponsor
|
Name |
LADY HARDINGE MEDICAL COLLEGE |
Address |
SHAHEED BHAGAT SINGH MARG NEW DELHI |
Type of Sponsor |
Government 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 NISHANT KUMAR |
LADY HARDINGE MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIOLOGY
SHAHEED BHAGAT SINGH MARG
DELHI Central DELHI |
9811934659
kumarnishant@yahoo.co.uk |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ETHICS COMMITTE FOR HUMAN RESEARCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (3) ICD-10 Condition: C16||Malignant neoplasm of stomach, (4) ICD-10 Condition: C17||Malignant neoplasm of small intestine, (5) ICD-10 Condition: C18||Malignant neoplasm of colon, (6) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (7) ICD-10 Condition: C25||Malignant neoplasm of pancreas, (8) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, (9) ICD-10 Condition: E669||Obesity, unspecified, (10) ICD-10 Condition: K45||Other abdominal hernia, (11) ICD-10 Condition: C67||Malignant neoplasm of bladder, (12) ICD-10 Condition: C64||Malignant neoplasm of kidney, except renal pelvis, (13) ICD-10 Condition: K21||Gastro-esophageal reflux disease, (14) ICD-10 Condition: K25||Gastric ulcer, (15) ICD-10 Condition: K26||Duodenal ulcer, (16) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (17) ICD-10 Condition: N25-N29||Other disorders of kidney and ureter, (18) ICD-10 Condition: M84||Disorder of continuity of bone, (19) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
propofol and dexmedetomidine |
infusion dexmedetomidine @1mcg/kg over 10 min folowed by infusion dexmedetomidine 0.5mcg/kg/hr. infusion propofol 200mcg/kg/min to maintain a BIS of 40-50 |
Comparator Agent |
Propofol and Ketamine |
INFUSION KETAMINE @1MG/KG OVER 10 MINS FOLLOWED BY INFUSION KETAMINE 0.5MG/KG/HR
INFUSION PROPOFOL 200MCG/KG/MIN TITRATED TO MAINTAIN A BIS OF 40-50 |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1.ASA I and ASA II
2.Undergoing elective surgery of duration 1-4 hours
|
|
ExclusionCriteria |
Details |
1.Any known allergy to drugs used in the study.
2.Known psychiatric illness.
3.Narrow angle glaucoma.
4.Addiction to drugs and alcohol.
5.Chronic opioid therapy
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time taken to achieve Modified Aldrete Score of ≥9 (Mean±SD) using propofol with ketamine or dexmedetomidine |
postoperative every minute till Modified Adrette Score is more than or equal to 9 |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.haemodynamic complications (bradycardia, tachycardia, hypotension, hypertension)
2.Mean Bi-spectral index
3.Total propofol requirement (mcg/kg/min; Mean dose±SD)
4.Total 24hrs analgesic requirement
5.post-operative nausea and vomiting
6.irrelevant talk, hallucination
7.explicit recall |
intraoperative haemodynamics every 5 minutes and BIS every 10 min
At the end of surgery and 24 hours postoperative |
|
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
|
N/A |
Date of First Enrollment (India)
|
04/02/2021 |
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="5" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Total Intravenous Anaesthesia (TIVA) is a technique of general anaesthesia which uses a combination of agents given exclusively by the intravenous route without the use of inhalation agents. Till recently, inhalational anaesthetic agents have remained the routine choice for maintenance of anaesthesia, but they have their own drawbacks and shortcomings such as cost, different specific vaporizers which require repeated maintenance and scavenging system to prevent pollution of operation room.1 However, in terms of global warming potential, inhalational anaesthetic agents still remain a big hazard for the environment.2 Apart from avoiding these, TIVA decreases post-operative nausea and vomiting (PONV), lessens neurohumoral response, avoids distension of air-filled spaces and postoperative diffusion hypoxemia.1 Opioids are very commonly used in modern methods of anaesthesia. The use of opioids is based on their ability to provide analgesia during the peri operative period.3 Opioids used as the part of a balanced anaesthesia are known to have a lot of side effects such as sedation, respiratory depression, post-operative nausea and vomiting, urinary retention, constipation and opioid induced hyperalgesia.4 These side effects can delay post-operative recovery and early mobilization of the patient. Apart from this opioid are also known for their physical dependence. Opioid free total intravenous anaesthesia provides a viable alternative for these problems. The principle of opioid free anaesthesia is to gain analgesic effects from different drugs while minimizing side effects particularly those of opioids,5 with added advantages of decreased postoperative nausea and vomiting and analgesic requirement post operatively. Ketamine, an NMDA antagonist and dexmedetomidine, an alpha 2 adrenoreceptor agonist have been used in lieu of opioids to provide analgesia intraoperatively. Their use has strengthened the role of opioid free TIVA for maintenance of anaesthesia. This study is being planned to compare the postoperative recovery profile of patients receiving opioid free TIVA with either ketamine or dexmedetomidine. |