| CTRI Number |
CTRI/2019/07/020357 [Registered on: 24/07/2019] Trial Registered Prospectively |
| Last Modified On: |
23/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between intravenous propofol (sleep inducing agent) and inhalation sevoflurane (sleep inducing agent) for ease of classic laryngeal mask airway insertion in patients undergoing elective surgery |
|
Scientific Title of Study
|
A prospective randomized single blinded comparative study between intravenous propofol and inhalation sevoflurane for ease of classic laryngeal mask airway insertion in patients undergoing elective surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilanjan Chakraborty |
| Designation |
Post graduate trainee |
| Affiliation |
Midnapore Medical College |
| Address |
Department of Anaesthesiology, Midnapore Medical College, Paschim Medinipur, Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
8334826702 |
| Fax |
|
| Email |
neelchak86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROSENJIT MUKHERJEE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Midnapore Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, MIDNAPORE MEDICAL COLLEGE AND HOSPITAL PASCHIM MEDINIPUR
Medinipur
WEST BENGAL
721101
India |
| Phone |
9433727718 |
| Fax |
|
| Email |
docposhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROSENJIT MUKHERJEE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Midnapore Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, MIDNAPORE MEDICAL COLLEGE AND HOSPITAL PASCHIM MEDINIPUR
North Twentyfour Parganas
WEST BENGAL
721101
India |
| Phone |
9433727718 |
| Fax |
|
| Email |
docposhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of the principal, Midnapore medical college and hospital, Vidyasagar road. Paschim Medinipur- 721101 |
|
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Primary Sponsor
|
| Name |
Midnapore Medical College |
| Address |
Midnapore Medical College, Pasachim Medinipur
Midnapore
WestBengal
721101 |
| Type of Sponsor |
Government 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 Nilanjan Chakraborty |
Surgery OT complex,Mother and Child Hub |
Midnapore Medical College, Paschim Medinipur,Midnapore-721101
Medinipur
WEST BENGAL |
8334826702
neelchak86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
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 |
| Intervention |
Classic laryngeal airway insertion with 1% intravenous propofol |
Patients will be randomly allocated into two groups (P and S) of 40 patients each. Group P will receive Propofol and group S will receive Sevoflurane. Premedication with injection Ondansetron 4mg IV, injection Glycopyrrolate 0.2mgIV and injection Fentanyl 2mcg/kg IV will be given to all patients. Preoxygenation with 100% Oxygen @ 8L/min. using Magill circuit with 2L reservoir bag will be given for 3 min. Patient’s baseline vital data such as heart rate (HR), mean arterial blood pressure (MAP), SpO2 will be recorded. P group will be given injection Propofol 2.5mg/kg body weight @ 40mg/10s. . Loss of verbal contact will be assessed by the response to calling out the patient’s name. Loss of eyelash reflex is the desired end point for induction in both techniques. After this, jaw relaxation will be assessed and if not adequate, it will be reassessed after every 30 s up to a maximum of four attempts, each time preceded by Propofol boluses of 0.5 mg/kg i.v . Once jaw relaxation is adequate, LMA insertion will be attempted. LMA will be inserted by the classical method described by Dr. Archie I J Brain. |
| Comparator Agent |
Classic laryngeal airway insertion with inhalational sevoflurane |
S group will be given 8% Sevoflurane along with Oxygen 8L/min using Magill (Mapleson A) circuit with 2L reservoir bag and patients will be instructed to take and hold it as long as they can (3). Loss of consciousness (LOC) will be confirmed by testing for the loss of eyelash reflex. Then the ease of mouth opening will be assessed (possible or impossible) by another anaesthesiologist. If mouth opening is not possible, another attempt will be taken every 30 s up to a maximum of four attempts. An attempt to open the mouth will be considered as an attempt of LMA insertion. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS I & II
2. Weight between
3. 30 kg to 70 kg
4. Surgeries where LMA can be used.
|
|
| ExclusionCriteria |
| Details |
1. Unwilling patients
2. ASA III & IV
3. Allergy to propofol
4. Oral surgeries
5. Heavy smokers (more than 20 cigarettes in a day)
6. Upper respiratory tract infection
7. Emergency surgeries.
8. Conditions where LMA insertion could not be done after four attempts.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sevoflurane is as good an induction agent as propofol and it is advantageous for its hemodynamic stability is our expected outcome. |
August 2019 to July 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the hemodynamic changes among two study groups.
2.Complications of LMA insertion.
|
August 2019 to July 2020 |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| 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
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
To compare ease of insertion of classic laryngeal mask airway(LMA) in patients undergoing elective surgery using intravenous propofol and inhalational sevoflurane. Propofol is the most commonly used induction agent for LMA insertion but it causes significant hemodynamic changes. On the other hand sevoflurane does not causes significant hemodynamic changes. Expected outcome of this study is sevoflurane is as good an induction agent as propofol and it is advantageous for its hemodynamic stability.
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