| CTRI Number |
CTRI/2024/07/070090 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare post operative
recovery time with propofol plus ketamine vs propofol plus Dexmedetomidine by target control
infusion in patients undergoing
laparoscopic cholecystectomy
|
|
Scientific Title of Study
|
A randomised clinical study to compare time to post-operative
recovery using propofol with either ketamine or
dexmedetomidine by target control
infusion in patients undergoing
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 |
Munira Sidhpurwala |
| Designation |
post graduate student |
| Affiliation |
Lady hardinge medical college |
| Address |
Department of anaesthesia, lady Hardinge medical college ,shahid bhagat Singh marg,delhi
Central
DELHI
110001
India |
| Phone |
8319454553 |
| Fax |
|
| Email |
sidhpurwalamunira2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anshu Gupta |
| Designation |
Director professor |
| Affiliation |
Lady hardinge medical college |
| Address |
Department of anaesthesia, lady Hardinge medical college ,shahid bhagat Singh marg,delhi
Central
DELHI
110001
India |
| Phone |
9711000264 |
| Fax |
|
| Email |
anshuguptabr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishant kumar |
| Designation |
Professor |
| Affiliation |
Lady hardinge medical college |
| Address |
Department of anaesthesia, lady Hardinge medical college ,shahid bhagat Singh marg,delhi
Central
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 |
Department of anaesthesia, lady hatrdinge medical college, shahid 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 |
| Munira |
lady hardinge medical college |
department of anaesthesia, lady Harding medical college and associated hospitals, New Delhi
Central
DELHI |
8319454553
sidhpurwalamunira2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Lady Hardinge medical college and associated hospitals New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
Induction of anaesthesia dexmedetomidine with Cp of 1.2 ng/ml over10 minutes
Analgesia will be maintained by with TCI dexmedetomidine (group B) with Cp of 0.6 ng/ml
|
| Comparator Agent |
ketamine |
induction anaesthesia with ketamine with Cp of 600 ng/ml over 10 minutes
Analgesia will be maintained by TCI ketamine (group A) with Cp of 300 ng/ml
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 18-65 yrs.
2. ASA I and ASA II.
3. Patients undergoing laparoscopic cholecystectomy.
|
|
| ExclusionCriteria |
|
|
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 |
Comparison of mean/ median time taken to achieve Modified Aldrete score of ≥9.
|
At the end of anaesthesia
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Mean/ median propofol consumed during surgery.
• Proportion of patients with haemodynamic complications such as hypotension, hypertension, bradycardia, tachycardia.
• Proportion of patients with irrelevant talk & hallucination.
• Proportion of patients with postoperative nausea & vomiting.
• Mean/ median post-operative analgesic requirement within 24 hours of surgery.
• Proportion of patients with explicit recall
|
1 At the end of anaesthesia
2 Intra operative period
3 At the end of anaesthesia
4 At the end of anaesthesia
5 First 24 hrs of post operative period
6 First 24 hrs of post operative period |
|
|
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 4 |
|
Date of First Enrollment (India)
|
13/07/2024 |
| 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="2"
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
|
Total intravenous anesthesia (TIVA) is a technique of general anesthesia which uses a combination of agents given via syringe pump exclusively by the intravenous route without the use of inhalation agents, which can be delivered reliably using target controlled infusion (TCI). TCI is a more advanced method of IV drug infusion, which requires setting target plasma or target effect-site concentrations using a special infusion pump. Data on the pharmacokinetic parameters of the drug are programmed in the pump and the pump software. 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. 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. Analgesic effects, however, can be gained from different drugs while minimizing side effects particularly those of opioids, with added advantages of decreased postoperative nausea and vomiting and analgesic requirement post operatively. Ketamine is a phencyclidine derivative. It provides excellent amnesia and analgesia, preserves muscle tone with maintaining airway reflexes and spontaneous respiration. It is postulated that combining propofol–ketamine may preserve sedative and analgesic efficacy while minimizing their respective adverse effects, It has a perioperative sedative, analgesic and anxiolytic properties similar to benzodiazepines but being α2 adrenoceptor agonist it has less side effects. Justification: TIVA: use of intravenous agents to provide anaesthesia TCI: targeted infusion of drugs Propofol, opioids, dexmedetomidine and ketamine: safely delivered by TCI
Combinations of propofol with opioids have been studied with respect to TIVA, but there are limited studies to compare propofol with either dexmedetomidine or ketamine by target control infusion regarding post-operative recovery in patients
|