| CTRI Number |
CTRI/2023/01/049283 [Registered on: 30/01/2023] Trial Registered Prospectively |
| Last Modified On: |
29/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
SPACING TIME INTERVALS OF FENTANYL, TO DECREASE REQUIREMENT OF PROPOFOL IN GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
A STUDY OF EFFECT OF VARYING TIME INTERVALS BETWEEN FENTANYL AND PROPOFOL ON PROPOFOL REQUIREMENT FOR INDUCTION OF GENERAL ANESTHESIA : A RANDIMISED PROSPECTIVE CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRATHVI B |
| Designation |
Post graduate student, department of anaesthesia |
| Affiliation |
SDM Medical college and hospital |
| Address |
Department of anaesthesiology, SDMCMSH, Manjushree nagar, sattur, dharwad
Dharwad
Karnataka
580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9945619565 |
| Fax |
|
| Email |
Prathvibhat25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUPREETH R SHETTY |
| Designation |
Associate professor |
| Affiliation |
SDM Medical college and hospital |
| Address |
Dr Supreeth R Shetty
Associate professor
Department of anaesthesia
SDM medical college and hospital, Sattur,Dharwad-580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9945619565 |
| Fax |
|
| Email |
Supreethrshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUPREETH R SHETTY |
| Designation |
Associate professor |
| Affiliation |
SDM Medical college and hospital |
| Address |
Dr Supreeth R Shetty
Associate professor
Department of anaesthesia
SDM medical college and hospital, Sattur,Dharwad-580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9945619565 |
| Fax |
|
| Email |
Supreethrshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDMCMSH Manjushree nagar sattur dharwad |
|
|
Primary Sponsor
|
| Name |
SDM Medical college |
| Address |
SDM medical college and hospital, sattur, Dharwad -580009 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr prathvi |
SDM College of medical sciences and hospital |
Department of anaesthesia
SDM College of medical science and hospital(SDMCMSH)
Manjushree Nagar, Sattur, Dharwad -580009
Karnataka
Dharwad
KARNATAKA |
948002250
Prathvibhat25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl ,propofol |
Group 1: patients in this group propofol is administered after 1 min after fentanyl injection
Group 2: patients in this group will be Administered propofol after 3min after propofol injection
Group 3: patients will be Injected propofol after 5min after fentanyl injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to participate in the study
2.Patients undergoing elective surgery under general anaesthesia with endotracheal intubation
3.ASA physical status 1 and 2
4.Patients aged 18-60 years of either sex |
|
| ExclusionCriteria |
| Details |
1.patient refusal
2.BMI more than or equal 30kg/m2
3.anticipated difficult airway
4.history of allergy to drugs like propofol
5.history of alcohol/drug use
6.Respiratory,cerebrovascular, renal and cardiovascular diseases including uncontrolled hypertension
7.Receiving any drugs likely to affect requirement of propofol /hemodynamic changes |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the dose requirement of propofol in induction of general anaesthesia by delaying its injection after administration of fentanyl. |
1minute, 3minutes and 5minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare hemodynamic changes like hypotension, buckling, vocalisation |
1minute 3minute and 5minutes |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/02/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Propofol is a common intravenous anesthetic agent for the induction of general anesthesia. It is one of the drugs particularly suitable for general anaesthesia on account of its rapid recovery characteristics. A major drawback of propofol would be greater degree of hypotension relative to other hypnotic agents. Decreasing the induction dose of propofol can minimize the hemodynamic changes before intubation .An opioid when administered prior to propofol reduces the requirement of propofol and improves hemodynamic stability. Fentanyl is a potent synthetic mu-receptor agonist, and is the most widely used intravenous opioid for intraoperative analgesia in most parts of the world. Fentanyl gets distributed rapidly from plasma to highly vascular tissues and 80% of the injected dose leaves plasma in 5 min.When administered prior to intravenous induction, fentanyl acts synergistically with propofol and also attenuates hemodynamic response to laryngoscopy and endotracheal intubation. This study compares the effects of varying intervals between fentanyl and propofol administration on the propofol requirement for induction of general anaesthesia. Patients will be studied in this randomized prospective observational study.
Induction of anaesthesia will be done using Inj.Fentanyl 2mcg/kg will be administered. Group 1 :patients will be given propofol injection immediately after fentanyl injection. Group 2 :will receive propofol 3 min after fentanyl injection Group 3 :will be given propofol after 5min after fentanyl injection. Propofol will be injected slowly at the rate of 1ml/3sec till loss of verbal contact. Total dose of propofol required per kg body weight for induction will be noted. Next the vital parameters like heart rate, noninvasive systolicbloodpressure(SBP), diastolic blood pressure(DBP), mean arterial pressure(MAP) will be recorded from the baseline , every minute till the completion of induction of anaesthesia. Vital parameters will be recorded at 0, 1 ,2, 3 , 4 and 5 minutes following intubation. The recordings will then be tabulated and analyzed using SPSS.
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