| CTRI Number |
CTRI/2023/09/057874 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
19/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does clonidine or melatonin reduce pain after brain tumour surgeries ? |
|
Scientific Title of Study
|
Comparison of effect of preoperative melatonin and clonidine on postoperative pain in patients undergoing craniotomy for supratentorial tumours - a randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanghita Layek |
| Designation |
DrNB trainee, Neuroanaesthesiology |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata, 185, Acharya Jagadish Chandra Bose Road, Elgin
Department of Neuroanaesthesiology,
Kolkata
WEST BENGAL
700017
India |
| Phone |
8145780194 |
| Fax |
|
| Email |
sanghita.layek@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bibhukalyani Das |
| Designation |
Head of the department, Neuroanaesthesiology |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata, 185, Acharya Jagadish Chandra Bose Road, Elgin
Kolkata
WEST BENGAL
700017
India |
| Phone |
9836000519 |
| Fax |
|
| Email |
bibhukalyanidas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanghita Layek |
| Designation |
DrNB trainee, Neuroanaesthesiology |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Department of Neuroanaesthesiology,Institute of Neurosciences Kolkata, 185, Acharya Jagadish Chandra Bose Road, Elgin.
WEST BENGAL
700017
India |
| Phone |
8145780194 |
| Fax |
|
| Email |
sanghita.layek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences Kolkata, 185, Acharya Jagadish Chandra Bose Road, Elgin, Kolkata, West Bengal 700017 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [No 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 Sanghita Layek |
Institute of Neurosciences Kolkata , 185, Acharya Jagadish Chandra Bose Road, Elgin |
Department of Neuroanaesthesiology
Kolkata
WEST BENGAL |
8145780194
sanghita.layek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Neurosciences Kolkatae |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (3) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (4) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (5) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
premedication given before induction of anaesthesia |
oral clonidine 50 mcg given the night before surgery and 100 mcg one hour before induction of anaesthesia |
| Intervention |
Premedication given before induction of anaesthesia |
Oral melatonin and clonidine given the night before and one hour before induction of anaesthesia-two oral doses given at two points of time, not for any duration of time |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Karnofsky performance score 80-100
Patients with intact higher mental functions
Patients scheduled for elective craniotomies for supratentorial tumors
Patients who have signed informed consent form |
|
| ExclusionCriteria |
| Details |
Patients with hypersensitivity to any drug
History of congestive heart failure, valvular heart disease
History of renal or hepatic disease
History of neuropsychiatric disorders
Pregnant patients
Patients on beta blockers, anti platelet drugs, anticoagulants, extended release formulation of any analgesic or any psychotropic drugs in the present or in the past
Patients not getting extubated immediately after surgery
Duration of surgery more than 4 hours |
|
|
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 |
1. The primary objective is to assess difference
a) in 100 point VAS score postoperatively
b) in fentanyl consumption in the postoperative period
between melatonin versus clonidine as oral premedicants in craniotomies for supratentorial tumors.
|
preoperative haemodynamics,
intraoperative haemodynamics
postoperative haemodynamics,VAS score 6, 12, 24 & 48 hours after extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Comparison in perioperative state a) anxiety & sedation b) haemodynamic stability and c) adverse effects between the two groups. |
preoperative haemodynamics, sedation score & anxiety score
intraoperative haemodynamics
postoperative haemodynamics and sedation score at 6, 12, 24 and 48 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The incidence, magnitude and duration of acute pain experienced by neurosurgical patients after various brain operations are not known precisely. Postoperative pain was more common than generally assumed (60%). In two-thirds of the patients with postoperative pain, the intensity was moderate to severe. Pain most frequently occurred within the first 48 hours after surgery. Patients with high levels of preoperative anxiety require higher doses of anaesthetic induction agents and recover poorly. Preoperative anxiety and perioperative pain may be associated with each other. Preoperative anxiety serves a critical role in the chain of events that control the postoperative pain response. High level of preoperative anxiety is associated with an increased requirement of analgesics in the postoperative period. Postoperative pain management is an unorganized sphere owing to the dearth of standard analgesic protocols. In this study, we will give oral melatonin and oral clonidine as premedications the night before surgery and one hour before surgery. The primary objective is to assess difference in 100 point VAS score postoperatively and in fentanyl consumption in the postoperative period between melatonin versus clonidine in craniotomies for supratentorial tumours. The secondary objective is to compare perioperative anxiety, sedation, haemodynamic stability and adverse effects between the two groups. |