| CTRI Number |
CTRI/2018/07/014794 [Registered on: 10/07/2018] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE EVALUATION OF RECOVERY CHARACTERISTICS WITH PROPOFOL AND SEVOFLURANE IN DAY CARE SURGERY |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF RECOVERY CHARACTERISTICS FROM ANAESTHESIA WITH PROPOFOL AND SEVOFLURANE IN DAY CARE SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saravanakumar S |
| Designation |
Junior resident |
| Affiliation |
GGS Medical college and hospital |
| Address |
Anaesthesia department main operation theater 2nd floor Guru Gobind Singh medical college, sadiq road, faridkot, punjab 151203
Anaesthesia department main operation theater 2nd floor Guru Gobind Singh medical college, sadiq road, faridkot, punjab 151203
Faridkot
PUNJAB
151203
India |
| Phone |
9789657358 |
| Fax |
|
| Email |
drsaravanakumar009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurpreet Singh |
| Designation |
Proffesor, M.D Anesthesia |
| Affiliation |
GGS medical college and hospital |
| Address |
HIG 694,PHASE 9, MOHALI-160062
Guru Gobind Singh medical college, sadiq road, faridkot, punjab
Faridkot
PUNJAB
151203
India |
| Phone |
7973229449 |
| Fax |
|
| Email |
drgurpreetsinghggsmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurpreet Singh |
| Designation |
Proffesor, M.D Anesthesia |
| Affiliation |
GGS medical college and hospital |
| Address |
HIG 694,PHASE 9, MOHALI-160062
Guru Gobind Singh medical college, sadiq road, faridkot, punjab
Faridkot
PUNJAB
151203
India |
| Phone |
7973229449 |
| Fax |
|
| Email |
drgurpreetsinghggsmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| GGS medical college and hospital, sadiq road, faridkot 151203 |
|
|
Primary Sponsor
|
| Name |
Dr SARAVANAKUMAR S |
| Address |
room no 32, pg gents hostel, Guru Gobind Singh medical college, sadiq road, faridkot, punjab 151203 |
| Type of Sponsor |
Other [self] |
|
|
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 Saravanakumar S |
GGS medical college and hospital |
GGS medical college and hospital,
sadiq road, faridkot 151203
Faridkot
PUNJAB |
9789657358
drsaravanakumar009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thesis and ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, who will be operated upon for various elective day care surgical procedures under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PROPOFOL |
GENERAL AND PSYCHOMOTOR RECOVERY CHARACTERISTICS FROM ANAESTHESIA IN DAY CARE SURGERY with sevoflurane |
| Intervention |
SEVOFLURANE |
GENERAL AND PSYCHOMOTOR RECOVERY CHARACTERISTICS FROM ANAESTHESIA IN DAY CARE SURGERY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II patient
Various elective day care surgical procedures under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal.
2) Patients who have known allergy from
study drugs.
3) Pregnant and lactating womens.
4) Patients with a history of underlying
psychological disorder, drug or alcohol abuse.
|
|
|
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 |
| Response to commands |
general recovery characteristics every minutes and Psychomotor recovery characteristics every hour upto 12th hour in post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters & adverse effects |
every 5 mins for first 30 mins then every 10 mins till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/07/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Jellish W, Lien C, Fontenot H, Hall R. The Comparative Effects of Sevoflurane Versus Propofol in the Induction and Maintenance of Anesthesia in Adult Patients.AnesthAnalg.1996;82:479-85.
2. Frink EJ, Malan TP, Atlas M, Dominguez LM, DiNardo JA, Brown BR. Clinical comparison of sevoflurane and isoflurane in healthy patients.AnesthAnalg. 1992;74:241–5.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
SUMMARY A COMPARATIVE EVALUATION OF RECOVERY CHARACTERISTICS FROM ANAESTHESIA WITH PROPOFOL AND SEVOFLURANE IN DAY CARE SURGERY INTRODUCTION: Office-based surgery is becoming increasingly popular because of its cost-saving potential. Both Propofol and Sevoflurane are commonly used in the ambulatory setting because of their favourable recovery profiles. This clinical investigation is designed to compare the general and psychomotor recovery characteristics of propofol and sevoflurane when used alone. AIMS AND OBJECTIVES: 1) To evaluate the patients general and psychomotor recovery profile when using Propofol based day care anaesthesia techniques. 2) To evaluate the patients general and psychomotor recovery profile when using Sevoflurane based day care anaesthesia techniques. 3) To compare both these drugs on general and psychomotor recovery profile when using for day care anaesthesia techniques. MATERIALS AND METHODS: The present study will be conducted in a randomized manner in the department of Anaesthesiology, GGS Medical College and hospital, Faridkot |