| CTRI Number |
CTRI/2020/12/029541 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
10/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison Of Effects Of Pregabalin and Clonidine On Pain, Sedation and Recovery From General Anesthesia After Laparoscopic Hysterectomy |
|
Scientific Title of Study
|
A Comparative Study Of Effects Of Oral Pregabalin Versus Oral Clonidine As Premedication On Early Post-Operative Pain, Sedation And Recovery Score In Patients Posted For Laparoscopic Hysterectomy Under General Anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eesha Banerjee |
| Designation |
Pg Student |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
| Address |
Roon no 508
Fifth Floor
PG hostel
Campus 2
IMS AND SUM Hospital
Department of Anesthesia Critical Care and Pain Medicine
K8 Kalinganagar
Ghatikia
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7501724995 |
| Fax |
|
| Email |
eesha5banerjee70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Diptimayee Mallik |
| Designation |
Associate Professor |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
| Address |
Doctor’s Enclave
1st floor
IMS AND SUM Hospital
Department of Anesthesia Critical Care and Pain Medicine
K8 Kalinganagar
Ghatikia
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9861159151 |
| Fax |
|
| Email |
dr.diptimayee2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
EESHA BANERJEE |
| Designation |
Pg student |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
| Address |
Room 508
Fifth floor
PG hostel
Campus 2
IMS and SUM Hospital
Department of Anesthesia Critical Care and Pain Medicine
K8 Kalinganagar
Ghatikia
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7501724995 |
| Fax |
|
| Email |
eesha5banerjee70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences and SUM Hospital
Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences And SUM Hospital |
| Address |
IMS and SUM Hospital
K8 Kalinganagar
Ghatikia
Bhubaneswar
Odisha
751003 |
| Type of Sponsor |
Private 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 Eesha Banerjee |
IMS and SUM Hospital |
Ot Complex 1
Ground floor
Near Labor Room
K8 Kalinganagar
Ghatikia
Bhubaneswar
Odisha
751003
Khordha
ORISSA |
7501724995
eesha5banerjee70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N95||Menopausal and other perimenopausal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab Clonidine |
Preemptive use of single dose tablet clonidine(150 mcg) given orally with a sip of water 60 minutes prior to induction of general anaesthesia. |
| Comparator Agent |
Tab glucose |
Preemptive use of single dose tablet glucose(60 mg) given orally with just a sip of water 60 minutes prior to induction of general anaesthesia. |
| Intervention |
Tab pregabalin |
Preemptive use of single dose tablet pregabalin(75 mg) given orally with a sip of water 60 minutes prior to induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients belonging to ASA Grade-I status
2. Patients posted for elective laparoscopic hysterectomy
|
|
| ExclusionCriteria |
| Details |
1. Refusal of the patient to participate in the study
2. Patients belonging to ASA Grade II/III/IV status
3. Any known allergies to Clonidine or Pregabalin
4. Patients with any chronic pain syndrome under treatment with any GABAergic drugs
5. Patients in whom laparoscopy was converted to laparotomy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of pain assessed by 10-point Visual Analogue Scale (VAS) |
At baseline, 1, 2, 4, 6, 12 and 24 hours respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of Sedation measured by Ramsay Sedation Scale(RSS) |
At baseline, 6, 12 and 24 hours respectively. |
| Recovery measured using Modified Aldrete score |
Before discharge to ward from the recovery room |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A comparative study of preemptive oral pregablin (75mg) and oral clonidine (150 mcg) to assess the degree of analgesia via VAS score, level of sedation via Ramsay sedation scale and the recovery via Modified Aldrete score in female patients posted for laparoscopic hysterectomy after the end of the surgery. |