| CTRI Number |
CTRI/2011/06/001786 [Registered on: 06/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
04/06/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing anxiety level before surgery |
|
Scientific Title of Study
|
A comparative study to see the efficacy of intranasal dexmeditomedine versus oral alprazolam as a premedication agent in morbid obese patients undergoing bariatric surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Jayaraman |
| Designation |
Senior Consultant Anesthesiologist |
| Affiliation |
|
| Address |
Max Superspeciality Hospital East wing
New Delhi
DELHI
110017
India |
| Phone |
9811203658 |
| Fax |
|
| Email |
lakjayaraman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi jayaraman |
| Designation |
|
| Affiliation |
|
| Address |
Max Superspeciality Hospital East wing
New Delhi
DELHI
India |
| Phone |
9811203658 |
| Fax |
|
| Email |
lakjayaraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmi jayaraman |
| Designation |
|
| Affiliation |
|
| Address |
Max Superspeciality Hospital East wing
New Delhi
DELHI
India |
| Phone |
9811203658 |
| Fax |
|
| Email |
lakjayaraman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max superspeciality hospital Saket New Delhi 110017 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
|
| Type of Sponsor |
|
|
|
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 Lakshmi Jayaraman |
Max Superspeciality Hospital East wing |
Max Superspeciality Hospital East wing,-
New Delhi
DELHI |
9811203658
lakjayaraman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Morbid obese patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomedine |
Intanasal route
1 microgram/kg ideal body weight
Duration of action 90 minutes |
| Comparator Agent |
Alprazolam tablet |
Oral route
0.25 mg
Duration of treatment 90 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI 35
2. Hemodynamically stable
|
|
| ExclusionCriteria |
| Details |
1. Refusal to give consent
2. Known allergy to alpha2 agonists
3. Patients on psychotropic drugs
4. Recent cardiac events like coronary stenting, acute myocardial infarction
5. Mentally deranged patient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sedation as per RAmsay sedation score |
after 45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate ,Mean arterial pressure Saturation of oxygen |
BAseline
After 45 minutes
At tracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/03/2011 |
| 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="2"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Morbidly obese patients are candidates who are challenges for anaesthesiologists as they are associated with multiple comorbidities like obstructive sleep apnoea, difficult airway and difficult venous cannulations.etc. In view of their tendency to desaturation, sedative premedication should be used with great caution. The common antianxiety agent used is oral midazolam. Dexmeditomedine ,anDexmeditomedine, an alpha2 agonist is a newer drug, has unique propertiesunique properties including sedationincluding sedation, anxiolytic and analgesia with the unique characteristic of absence of respiratory depression. The sympatholytic and antinocciceptive properties of dexmeditomedine adds to the hemodynamic stability apart from preservation of airway reflexes . The sedation produced by dexmeditomedine has unique properties that it produces an unusually co-operative form and unique form of sedation in which the patient is calmly and easily aroused from sleep to wakefulness to allow task performance and excellent communication and can go back to sleep when not stimulated unlike other sedatives. The only other drug with similar pharmacological properties is clonidine. But the sedation and respiratory depression associated with clonidine makes it anit an unpopular option for premedication in this group of patients. Dexmedetomedine has found a definite place in the intraoperative management of morbid obese patients undergoing bariatric or non-bariatric procedures. The definitive role of Dexmeditomedine as a premedication in morbid obese patients undergoing bariatric and non-bariatric procedures has not been studied. The various modes of administration of Dexmeditomedine are by intravenous, intramuscular and intranasal methods. Intranasal method is a non-invasive method of drug administration where the drug is absorbed well by the vascular nasal mucosa and produces its effect rapidly within 20 minutes .The intranasal route also bypasses the first pass metabolism. Usually the intranasal method has been used in children undergoing various procedures. We will undertake a pilot study and study the efficacy of this drug as compared to midazolam on the effects of sedation and the hemodynamic response to laryngoscopy and tracheal intubation in morbid obese patients with OSA. |