| CTRI Number |
CTRI/2024/08/072483 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison Of Clinical Effect Of Ketamine Versus Fentanyl When Given In Combination With Propofol And Midazolam In Dilatation And Curettage Cases. |
|
Scientific Title of Study
|
Comparison Study Of Recovery Characteristics And Clinical Effect Of Ketamine Vs Fentanyl As An Adjuvant To Propofol And Midazolam In Dilatation And Curettage : A Randomized Double-Blind Interventional Study. |
| 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 Rajnikant Shandilya |
| Designation |
Junior Resident |
| Affiliation |
Heritage Institute of medical Sciences, varanasi |
| Address |
Heritage Institute Of Medical Sciences, Department Of Anaesthesiology, 4th Floor, NH:2(Grand Trunk Bypass road) , Bhadwar , Varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8549865405 |
| Fax |
|
| Email |
shandilya600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Mishra |
| Designation |
Professor |
| Affiliation |
Heritage Institute of medical Sciences, varanasi |
| Address |
Heritage Institute Of Medical Sciences, Department Of Anaesthesiology, 4th Floor, NH:2(Grand Trunk Bypass road) , Bhadwar , Varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9582113920 |
| Fax |
|
| Email |
akhil61086@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. ANKUR KUMAR |
| Designation |
Associate Professor |
| Affiliation |
Heritage Institute of medical Sciences, varanasi |
| Address |
Heritage Institute Of Medical Sciences, Department Of Anaesthesiology, 4th Floor, NH:2(Grand Trunk Bypass road) , Bhadwar , Varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
7351534940 |
| Fax |
|
| Email |
kumar.ankur2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Heritage Institute Of Medical Sciences, NH:2(Grand Trunk Bypass road) , Bhadwar , Varanasi, 221311, Uttar Pradesh , India |
|
|
Primary Sponsor
|
| Name |
Heritage Institute Of Medical Sciences |
| Address |
Heritage Institute Of Medical Sciences, NH:2(Grand Trunk Bypass road) , Bhadwar , Varanasi, 221311, Uttar Pradesh , India |
| 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 Rajnikant Shandilya |
Heritage Institute Of Medical Sciences |
Department Of Anaesthesiology,
Ot Complex , 4th Floor
Varanasi
UTTAR PRADESH |
8549865405
shandilya600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HIMS ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O029||Abnormal product of conception, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
KETAMINE VS FENTANYL |
After informed consent from the patient will be randomly divided into two groups.
Group A: Fentanyl , Midazolam , Propofol will be taken.
Group B : Ketamine , Midazolam , Propofol will be taken.
A peripheral intravenous (iv) line will be secured by 18G cannula and 10-12 mL/kg/h crystalloid solution will be started.
Patients will be premedicated with midazolam (1 mg i/v) before starting the procedure, and will receive supplementary oxygen (2-4 L/min) with a facemask.
Group A: patients who will receive 2mcg/kg Fentanyl slow intravenous injection. About 5 minutes after this Inj. Propofol will be given in the dose of 1mg/kg body weight till loss of consciousness. Group B: patients who will receive Ketamine 0.5 mg/kg iv slowly over 2 minutes. After 5 minutes Inj. Propofol will be given in the induction dose of 1 mg/kg body weight till the loss of consciousness.
The patients will be given an additional 0.5 mg/kg of bolus dose of Inj. Propofol iv when the patient will become light as will be indicated by rise in heart rate (HR), blood pressure (BP), lacrimation or any movement to surgical stimuli.
The total dose of propofol required for the procedure will be noted in both the groups. |
| Intervention |
Total Intravenous Anaesthesia |
Patient will be randomly divided into two groups.
Group A: Fentanyl , Midazolam , Propofol will be taken.
Group B : Ketamine , Midazolam , Propofol will be taken. Patients will be premedicated with midazolam (1 mg i/v) before starting the procedure in both groups.
Group A: patients who will receive 2mcg/kg Fentanyl slow intravenous injection. About 5 minutes after this Inj. Propofol will be given in the dose of 1mg/kg body weight till loss of consciousness.
Group B: patients who will receive Ketamine 0.5 mg/kg iv slowly over 2 minutes. After 5 minutes Inj. Propofol will be given in the induction dose of 1 mg/kg body weight till the loss of consciousness.
The patients will be given an additional 0.5 mg/kg of bolus dose of Inj. Propofol iv when the patient will become light as will be indicated by rise in heart rate (HR), blood pressure (BP), lacrimation or any movement to surgical stimuli. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA physical status classification I- II
2. Patients who were scheduled for Dilation & Curettage procedures.
|
|
| ExclusionCriteria |
| Details |
1. ASA physical status class III-IV
2. Allergic to study drugs
3. Patients denying consent for study.
4. Body mass index ≥ 35 kg/m2.
5. Chronic use of sedatives or opioid analgesics, and presence of a psychiatric disorder with chronic medical treatment, presence of liver or kidney dysfunctions, cardiac and endocrine diseases .
6. Non-cooperative patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare difference in Mean Modified Aldrete’s score & post-operatively and mean recovery time taken. |
AT 30 min, 1hour , 2 hour, 4 hrs & 6 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate difference in change in hemodynamic parameters during intra-operative from baseline
2) To assess difference in mean time duration taken for need for first rescue analgesia in both group.
3) To assess difference in % of cases who will experience side effects within 6 hours. |
1) From 1minutes,5,10,15,20, 25minutes and 30 minutes during intra-operative period.
|
|
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Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
19/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
In this study, two sedation protocols prepared by adding fentanyl or ketamine to the combination of midazolam-propofol applied on Dilatation & curettage will be compared with respect to patient satisfaction, side effects, and the technical characteristics such as the duration of the procedure and the total propofol consumption. MEASURING INDICATOR: Modified Aldrete’s score , Visual Analog Scale , Ramsay sedation scale, Time duration taken for need for first rescue analgesia.
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