| CTRI Number |
CTRI/2024/05/066874 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study comparing anxiety reducing effect of tablet Lorazepam and tablet Alprazolam. |
|
Scientific Title of Study
|
A prospective randomized double blinded comparison of the effect of tablet Lorazepam(1mg) and tablet Alprazolam(0.5mg) administered as oral premedication 3 hours prior to general anesthesia in patients undergoing elective laparoscopic cholecystectomy. |
| 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 Aruna Bharti |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh. |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh 226014
Department of anaesthesiology, SGPGIMS, Lucknow 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8871062490 |
| Fax |
|
| Email |
Cardarone@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Bharti |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh. |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh 226014.
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8871062490 |
| Fax |
|
| Email |
Cardarone@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipiendra Singh Solanki |
| Designation |
Junior resident, Department of Anaesthesiology |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh. |
| Address |
Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh.
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8871062490 |
| Fax |
|
| Email |
vipindrasolanki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute Of Medical Sciences, Lucknow,226014,Uttar Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institute of Medical sciences Lucknow Uttar pradesh |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh 226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vipiendra singh solanki |
Sanjay Gandhi Post Graduate Institute Of Medical Sciences. |
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh 226014
Lucknow
UTTAR PRADESH |
8871062490
VIPINDRASOLANKI@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commiittee ,Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ALPRAZOLAM Dose-0.5mg, Frequency- single tablet 3 hours prior to surgery. Route- Oral |
Anxiety level, amnesia and degree of sedation will recorded at the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2). |
| Comparator Agent |
LORAZEPAM Dose-0.5mg, Frequency- single tablet 3 hours prior to surgery. Route- Oral |
Anxiety level, amnesia and degree of sedation will recorded at the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient giving written consent.
2. Patients belonging to ASA grade I and II.
3. All genders
4. Normal BMI(18.5-25) subjects.
5. Patients in the age group (18-60years) undergoing elective laparoscopic cholecystectomy.
|
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent.
2. ASA grade III and IV.
3. Emergency surgeries.
4. Patient who had taken analgesic, sedative, antidepressant, and on antiepileptic drugs were excluded.
6. Patients with psychiatry illness will be excluded.
5. Patients with anticipated difficult airway.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objective –
1.Comparison of Alprazolam and Lorazepam in terms of anxiolysis by Hamilton anxiety rating scale (HAM-A).
2. Comparison of level of amnesia by MMSE score at time T1 and T2.
|
At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objectives – (i)Comparison of level of sedation by using Ramsey sedation score at time T1 & T2 |
At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2)
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Although
anxiolytic-sedative agents are used preoperatively since the advent of
anesthesia, many aspects of this treatment, including the intended effects
among which anxiolysis, and optimal agents, remain unclear. High levels of
preoperative fear and anxiety correlate with various unfavorable outcomes
,including increase in postoperative analgesia requirements, prolonged post anesthesia
care unit or hospital stay, it can lead to essential procedures being
postponed, delay postoperative recovery, and delayed negative psychological
effects.
Anxiolytic medication
is a common way to address preoperative anxiety. A common way to help patients
cope with preoperative anxiety is to administer anxiolytic medication, most
commonly benzodiazepines.
|