| CTRI Number |
CTRI/2024/01/061670 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Reduction of pain on propofol injection after 6% Hydroxyethyl starch |
|
Scientific Title of Study
|
Pre-Administration of 6% Hydroxyethyl Starch For Reduction of Pain on Propofol Injection: A Placebo Controlled Randomised 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 VEENA MATHUR |
| Designation |
HOD Department of anesthesiology JLN medical College and hospital |
| Affiliation |
JLN medical College and hospital |
| Address |
Department of Anesthesiology, New OT, first floor Jawahar Lal Nehru Medical College
Kalabhag
Ajmer
Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VEENA MATHUR |
| Designation |
HOD Department of Anesthesiology JLN medical College and hospital |
| Affiliation |
JLN medical College and hospital |
| Address |
Department of Anesthesiology, New OT, first floor Jawahar Lal Nehru Medical College and Hospital
Kalabhag
Ajmer
Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VEENA MATHUR |
| Designation |
HOD Department of Anesthesiology JLN medical College and hospital |
| Affiliation |
JLN Medical College and Hospital |
| Address |
Department of Anesthesiology, New OT, First floor , Jawahar Lal Nehru Medical College and Hospital
Kalabhag
Ajmer
Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology
JLN medical College and hospital,
Kalabhag road
Ajmer
Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical College |
| Address |
Kalabhag Ajmer Rajasthan |
| 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 VirukshaA |
Jawahar Lal Nehru Medical College and Hospital |
Department of Anesthesiology
New OT , First floor,
JLN Medical College and Hospital
Ajmer
RAJASTHAN |
9003473972
virukshaarun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Jawahar Lal Nehru Medical College and Hospital |
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% Normal saline |
With due approval from institutional ethical committee, placebo randomised study has been planned on 100 adult patients who will be undergoing General Anaesthesia, participants will be receiving 100 ml bolus over 3 to 5 minutes and then will be assessed for pain during propofol injection |
| Intervention |
6% hydroxyethyl starch |
with due approval from institutional ethical committee, placebo randomised study has been planned on 100 adult patients who will be undergoing General Anaesthesia, participants will be alloted into Group 6%HES receiving HES and group 0.9%NS receiving normal saline in 100 ml bolus over 3 to 5 minutes and then will be assessed for pain during propofol injection, pain recall post operatively, a written informed consent will be taken from participants prior to procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia
ASA class 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency surgery
Patients in whom hand or forearm veins are not accessible
Patients with comorbidites
Patient refusal |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain during propofol injection
Post operative pain recall |
Assessment of pain during propofol injection by Mc Crimick and hunter scale degree of pain during 2,5,10,20 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic changes
To compare the severity of propofol injection pain |
Baseline, 5minutes, 10 minutes, 20 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/01/2024 |
| 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="0"
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
|
After thorough preoperative assessment of each patient, written informed consent will be taken. on arrival in the operating room, an 18 G cannula is inserted. No analgesic premedication will be given. The study drug HES/ NS will be drawn up in two 50 ml syrings and administer it over three to 5 minutes.once the 100 ml bolus is over, all patients will be premedicated with inj.glycopyrolate 0.004mg/ kg if and inj. Tramadol 2 mg/ kg if.Preoxygenation will be done with 100% O2 for 3 minutes. Induction will be done using inj. Propofol 1.2 to 2.5 mg/kg if administered till loss of verbal contact. During propofol injection pain will be assessed Evert 5 to 10 seconds before the loss of verbal contact as 0- no pain, 1-mild pain,2- moderate and 3 - severe using Mc Crimick and hunter scale, tracheal intubation will be facilitated with inj.succinylscholine 2mg/ kg.Trachea will be intubated. General anaesthesia will be maintained with oxygen , inj atracurium and supplemented with inhalational sevoflurane.Routine ASA monitoring will be established. The vital parameters will be recorded. All patients will be asked to recall if there was pain during injection of propofol in the recovery room and incidence of pain was graded as no recall of pain present. |