| CTRI Number |
CTRI/2016/12/007618 [Registered on: 23/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
15/12/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EVALUATION OF EFFECT OF BLOWING IN A PIPE CONNECTED WITH BLOOD PRESSURE MEASURING MACHINE FOR REDUCING PROPOFOL PAIN |
|
Scientific Title of Study
|
Evaluation of efficacy of valsalva manuever for attenuating propofol injection pain |
| Trial Acronym |
EVAPIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay kumar |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Type4/68 SGPGIMS Lucknow 226014
Lucknow
UTTAR PRADESH
226014
India
Type4/68 SGPGIMS
Lucknow
UTTAR PRADESH
226014
India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222665528 |
| Fax |
05222668017 |
| Email |
drsanjaygupta9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay kumar |
| Designation |
Assistant professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Sgpgims, Lucknow
Type-4/68, Sgpgims, Lucknow-226014
India
UTTAR PRADESH
226014
India
Type-4/68, SGPGIMS, Lucknow-226014
Lucknow
UTTAR PRADESH
226014
India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222665528 |
| Fax |
05222668017 |
| Email |
drsanjaygupta9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay kumar |
| Designation |
Assistant professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Type-4/68, SGPGIMS, Lucknow-226014
UTTAR PRADESH
226014
India
Type-4/68, SGPGIMS, Lucknow-226014
Lucknow
UTTAR PRADESH
226014
India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222665528 |
| Fax |
05222668017 |
| Email |
drsanjaygupta9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute Of Medical Sciences Lucknow Uttar Pradesh India-226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute Of Medical Sciences Lucknow Uttar Pradesh India |
| Address |
Department of Anaesthesiology
Lucknow
UTTAR PRADESH
226014
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sanjay Kumar |
Operation theatre complex, First floor,Department of Anaesthesiology SGPGIMS |
Department of Anaesthesiology SGPGIMS, Lucknow-226014
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
8765974045
0522-2668017
drsanjaygupta9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
healthy or mild functional limitation , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group I ( Control) |
Acted as control and did not perform valsalva nor blew through a open tube. |
| Intervention |
Group II(Valsalva)
|
Group II(Valsalva) Patients were asked to blow into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec.just after finishing valsalva patients will be injected propofol
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I patients scheduled for surgery under general anaesthesia with propofol as an induction agent |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with communication problem
Cardiorespiratory disease
Chronic pain disorder, on preoperative analgesic medication,
History of egg allergy, soyabean oil
Inability to perform valsalva
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the analgesic efficacy of valsalva procedure in attenuating the propofol pain at induction of general anaesthesia |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/09/2015 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims and objectives:
Primary objective: To evaluate the efficacy of valsalva procedure in attenuating propofol injection pain at induction of general anaesthesia.
Methodology: Patients will be randomized with the help of a computer-generated table of random numbers into 2 groups of 40 each. Group I (Control): acted as control and did not perform valsalva; Group II (Valsalva): patients blowing into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec. Just after the intervention, all the patients will be receiving one-fourth of the total calculated dose of propofol over 5s and 15 s later till 1 minute and before the patients lost consciousness. One nursing staff who will be kept unaware of the study, will assess VAS and withdrawal response score.
Exclusion: Patients with communication problem, cardiorespiratory disease, chronic pain disorder, on preoperative analgesic medication, history of propofol allergy, history of drug abuse and inability to perform valsalva
Risks associated with the procedure are none as in ASA 1 patients; however, valsalva procedure has been reported to attenuate pain in animal studies and more so in humans for minimizing venous cannulation pain in adults and paediatric patients. We therefore wish to evaluate its efficacy in reducing the propofol injection pain. |