| CTRI Number |
CTRI/2011/06/001850 [Registered on: 30/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
30/06/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study and comparatively evaluate the ketamine-propofol with fentanyl-propofol combination for procedural sedation and analgesia in patients undergoing laparoscopic tubal ligation and to study which drug combination leads to an earlier recovery and discharge. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL OF KETAMINE-PROPOFOL AND FENTANYL-PROPOFOL COMBINATION FOR PROCEDURAL SEDATION AND ANALGESIA (PSA) IN LAPAROSCOPIC TUBAL LIGATION? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr mahmood ghazanwy |
| Designation |
post graduation in anesthesiology, 3rd year |
| Affiliation |
university of delhi |
| Address |
HSB-10
Lady Hardinge Medical College Campus
New Delhi
DELHI
110001
India |
| Phone |
09654355047 |
| Fax |
|
| Email |
yemg47@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr ranju singh |
| Designation |
|
| Affiliation |
professor |
| Address |
dept of anesthesia
LHMC Campus
New Delhi
DELHI
110001
India |
| Phone |
09811151285 |
| Fax |
|
| Email |
ranjusingh1503@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
dr ranju singh |
| Designation |
professor |
| Affiliation |
university of delhi |
| Address |
department of anesthesia
Lady Hardinge Medical College Campus
New Delhi
DELHI
110001
India |
| Phone |
09811151285 |
| Fax |
|
| Email |
ranjusingh1503@yahoo.com |
|
|
Source of Monetary or Material Support
|
| lady hardinge medical college
and S S K Hospital
university of delhi |
|
|
Primary Sponsor
|
| Name |
lady hardinge medical college and S S K Hospital university of delhi |
| Address |
Bhagat Singh Marg, delhi-110001 |
| Type of Sponsor |
Government 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 Ranju Singh |
Lady Hardinge Medical College and Associated Hospital |
Cannaught Place, Delhi-1
New Delhi
DELHI |
9811151285
ranjusingh1503@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| hospital ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
surgery under anesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fentanyl-propofol |
1.5 microgram/kg body wight fentanyl + 2mg/kg body weight propofol intravenously initially at the time of initiation of procedure followed by 0.5mg/kg propofol intravenously as required. duration of procedure varied from 7 minutes to 16 minutes. |
| Intervention |
ketamine-propofol |
0.5mg/kg body weight ketamine + 2mg/kg body weight propofol at the time of initiation of procedure followed by 0.5mg/kg propofol as required. Duration of procedure varied from 7 minutes to 16 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria-
American Society of Anesthesiologist physical status I patients aged 18-45 years female scheduled for laparoscopic tubal ligation.
Exclusion Criteria-
history of upper respiratory tract infections,
asthma,
allergy to propofol or ketamine,
receiving treatment for psychiatric disease,
receiving treatment for neuromuscular disease,
seizure disorder,
acid reflux,
hiatus hernia,
severe anemia,
gross obesity,
hepatic,cardiac or pulmonary disease. |
|
| ExclusionCriteria |
| Details |
Patients who have history of upper respiratory tract infections, asthma or allergy to propofol or ketamine or receiving treatment for any psychiatric or neuromuscular disease, patients with seizure disorder, acid reflux, hiatus hernia, severe anemia, gross obesity, hepatic, cardiac, or pulmonary diseases will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measures patient recovery time and discharge time using Ketamine-Propofol And Fentanyl-Propofol Combination For PSA In Laparoscopic Tubal Ligation. |
November 2009 to March 2011 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative recovery and duration of hospital stay and comfort and acceptability in the two groups
|
postoperative recovery and duration of hospital stay and comfort and acceptability in the two groups
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized control trial of ketamine-propofol and fentanyl-propofol combination for procedural sedation and analgesia in laparoscopic tubal ligation in ASA physical status I patients aged 18-45 years female. primary outcome measures Perioperative Hemodynamic Changes Using Ketamine-Propofol And Fentanyl-Propofol Combination For PSA In Laparoscopic Tubal Ligation. secondary outcome measures Postoperative Recovery And Duration Of Hospital Stay And Comfort And Acceptability In The Two Groups |