| CTRI Number |
CTRI/2014/01/004323 [Registered on: 17/01/2014] Trial Registered Prospectively |
| Last Modified On: |
27/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate whether a drug, levetiracetam decreases anxiety associated with elective laparoscopic gall bladder surgery |
|
Scientific Title of Study
|
Effect of pre-operative single dose Levetiracetam on anxiety associated with laparoscopic cholecystectomy: a randomized, double blinded, placebo controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurabh Kumar Das |
| Designation |
Consultant |
| Affiliation |
Nazareth Hospital |
| Address |
Department of Anesthesia and critical care. Nazareth Hospital, Laitumkhra, Shillong
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
8413031137 |
| Fax |
0364-2229385 |
| Email |
drsauravdas1977@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Kumar Das |
| Designation |
Consultant |
| Affiliation |
Nazareth Hospital |
| Address |
Department of Anesthesia and critical care. Nazareth Hospital, Laitumkhra, Shillong
MEGHALAYA
793003
India |
| Phone |
8413031137 |
| Fax |
0364-2229385 |
| Email |
drsauravdas1977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Kumar Das |
| Designation |
Consultant |
| Affiliation |
Nazareth Hospital |
| Address |
Department of Anesthesia and critical care. Nazareth Hospital, Laitumkhra, Shillong
MEGHALAYA
793003
India |
| Phone |
8413031137 |
| Fax |
0364-2229385 |
| Email |
drsauravdas1977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nazareth Hospital, Laitumkhra, Shillong, Meghalaya, pin: 793003 |
|
|
Primary Sponsor
|
| Name |
Nazareth Hospital |
| Address |
Nazareth Hospital, Laitumkhra, Shillong, Meghalaya, pin: 793003 |
| 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 |
| Saurabh Kumar Das |
Department of Anaesthesia and critical care, Nazareth Hospital |
Department of Anaesthesia and critical care, Nazareth Hospital, Laitumkhra, Shillong
East Khasi Hills
MEGHALAYA |
8413031137
0364-2229385
drsauravdas1977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Nazareth Hospital Shilong |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with physical status ASA I and II, are scheduled for elective laparoscopic cholecystectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Similar looking iron tablet |
One iron tablet will be given 4 hours before surgery. |
| Intervention |
Tablet levetiracetam 500mg |
Levetiracetam is a nobel anti epileptic which also has anxiolysis and analgesic property.One 500 mg levetiracetam tablet will be given 4 hours before surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with physical status ASA I and II, are scheduled for elective laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Age< 18 years or >70years
2. body mass index (BMI) <19 and >35 kg/m2
3. known sensitivity to study drugs
4. inability to tolerate oral medication and understand the anxiety (VAS) score,
5. has cardiac problem, renal or hepatic dysfunction, respiratory disease or any psychiatric problem.
6. on chronic pain medication, anticonvulsant or antidepressant.
7. pregnant patients
8. Patients are not giving consent to get enrolled in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| level of anxiety in terms of visual analogue score before surgery |
level of anxiety in terms of visual analogue score will be assessed before giving the study drug, at pre operative holding area before entering to operation theater, at operation theater just before administering anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sedation level |
just before giving the study drug, at pre operative holding area before entering to operation theater, on operation theater table just before induction of anesthesia |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2014 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Back ground: Preoperative anxiety has been described as a subjective feeling of apprehension, fear and nervousness. Levetiracetam is a novel anti epileptic drug and number of studies have shown that it also has anxiolysis property. Aims and Objectives: 1. To asses whether Levetiracetam decreases anxiety in terms of VAS in pre operative period 2. To find out whether the use of Levetiracetam causes sedation 3. To observe incidence of side effect if any
Material and Methods: 102 patients with physical status ASA I and II, who are posted for elective laparoscopic cholecystecymy will be divided into three groups two receive either tablet Levetiracetam 500 mg or placebo 4 hours before surgery. Pre operative anxiety will be assessed using visual analogue score before giving the study drug, at pre operative holding area and on operation theater table before induction of surgery. Sedation and incidence of side effect will be noted.
|