| CTRI Number |
CTRI/2023/06/053406 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effect of using hydroxyethyl starch with lignocaine for reduction of pain that occurs during administartion of propofol |
|
Scientific Title of Study
|
To evaluate add on effect of hydroxyethyl starch with lignocaine for pain relief following propofol administration |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawya Chugh |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College And Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
7837550387 |
| Fax |
|
| Email |
bhawyachugh48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawya Chugh |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College And Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
7837550387 |
| Fax |
|
| Email |
bhawyachugh48@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawya Chugh |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College And Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
7837550387 |
| Fax |
|
| Email |
bhawyachugh48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hopsital |
| Address |
Tagore Nagar,Civil Lines,Ludhiana 141001 Punjab 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 Gurpreeti Kaur |
Dayanand Medical College and Hospital |
Department of Anaesthesia Dayanand Medical College and Hospital Tagore Nagar,Civil Lines,Ludhiana 141001
Ludhiana
PUNJAB |
9779552017
grewal.preeti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee,Dayanand 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 |
Pre administration with 0.9% saline with 2% lignocaine during induction of anaesthesia for reducing pain of propofol injection |
Patients in group S will receive 50 ml of 0.9% Saline with 2% lignocaine (1mg/kg) intravenous over a period of 2 minutes. After this,intravenous injection of 1% propofol (2-3mg/kg) at rate of 0.5ml/sec will be given immediately for induction of anaesthesia.Pain score using NRS scale will be assessed every 15secs before patient loses respond to verbal commands |
| Intervention |
Pre administration with 6% Hydroxyethyl starch with 2% lignocaine during induction of anaesthesia for reducing pain of propofol injection |
Patients in group H will receive 50 ml of 6% Hydroxyethyl starch with 2% lignocaine (1mg/kg) intravenous over a period of 2 minutes. After this,intravenous injection of 1% propofol (2-3mg/kg) at rate of 0.5ml/sec will be given immediately for induction of anaesthesia.Pain score using NRS scale will be assessed every 15secs before patient loses respond to verbal commands |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of American Society of Anaesthesiologists(ASA) physical status I and II
18-65 yrs old
either gender
undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Emergency surgeries or hemodynamically unstable patients
Patients in whom hand or forearm veins will not be accessible
Uncontrolled hypertensives and diabetic patients
Patients with history of dyspnoea or NYHA III or IV
Patients with elevated serum creatinine
Patient refusal
Known history of allergy to propofol or Hydroxyethyl starch |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of pain on propofol injection |
During induction with propofol-pain score wil be assessed every 15 secs till loss of verbal command |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of pain on propofol injection using numerical rating scale |
During induction with propofol-pain score wil be assessed every 15 secs till loss of verbal command |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
10/06/2023 |
| 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="3"
Days="29" |
|
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
|
Propofol is the most widely used intravenous induction agent in anaesthesia. Pain on propofol injection is a common problem.Even with multimodal techniques,pain on propofol injection is not abolished completely. Hydroxyethyl Starch(HES),a colloid,is a clinically safe and well tolerated complex polysaccharide and has the capacity to modify endothelial cell junctions and permeablity of the vascular endothelium.Pre administration of HES may prevent contact activation of propofol which may in turn lead to reduced pain during propofol injection.A prospective,double blind,randomized study will be conducted on a total of 206 ASA I and II patients of age 18-65 yrs undergoing elective surgery under general anaesthesia who will be randomly allocated into group ’H’ and ’S’ of 103 each. Patients in group ’H’ will be administered 50 ml of 6% HES with 2% lignocaine(1mg/kg) while patients in group ’S’ will be administerd equal volume of 0.9% saline with 2% lignocaine 2mins before induction with 1% propofol(2mg/kg).The incidence and severity of pain on propofol injection will be calculated using Numerical Pain Rating Scale every 15 secs till loss of verbal command. Our aim of the study is to compare the incidence and severity of pain on propofol injetion pre administered with 6%HES with 2% lignocaine or 0.9% saline with 2% lignocaine during induction of anaesthesia. |