| CTRI Number |
CTRI/2024/09/074211 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
to assess the effect of Melatonin in patients undergoing awake craniotomy |
|
Scientific Title of Study
|
Effect of Melatonin Premedication in Patients Undergoing Awake Craniotomies: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Charu Mahajan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 4, Sixth floor, Neurosciences Center, AIIMS, New Delhi Room No 4, Sixth Floor, Department of Neuroanaesthesiology and Critical Care, AIIMS New Delhi DELHI 100029 India |
| Phone |
7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Charu Mahajan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 4, Sixth floor, Neurosciences Center, AIIMS, New Delhi Room No 4, Sixth Floor, Department of Neuroanaesthesiology and Critical Care, AIIMS New Delhi DELHI 100029 India |
| Phone |
7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Charu Mahajan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 4, Sixth floor, Neurosciences Center, AIIMS, New Delhi Room No 4, Sixth Floor, Department of Neuroanaesthesiology and Critical Care, AIIMS New Delhi DELHI 100029 India |
| Phone |
7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Dept of Neuroanaesthesiology and Critical Care, AIIMS, New Delhi |
| 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 |
| Charu Mahajan |
AIIMS, New Delhi |
Room No 4, Sixth Floor, Department of Neuroanaesthesiology and Critical Care South West DELHI |
011-2659-3474 91-011-686-2663 charushrikul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C71||Malignant neoplasm of brain, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C (Control group) |
Patients will receive oral mint pill (Placebo) on night before surgery and again two hours before surgery |
| Intervention |
Group M (Melatonin group) |
Patients will receive oral Tab Melatonin 5 mg on night before surgery and again two hours before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing awake craniotomy |
|
| ExclusionCriteria |
|
|
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 |
Patient Satisfaction Score measured on a 10-point Likert Scale ( 1 being the worst experience and 10
being the best )
|
one hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of oral melatonin premedication in decreasing preoperative anxiety in adult
patients undergoing awake craniotomy |
one hour after surgery |
| To assess sleep quality on the night before surgery |
morning of surgery |
To determine the consumption of intraoperative dexmedetomidine and fentanyl
|
At end of the surgery |
|
|
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)
|
25/09/2024 |
| 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
|
|
Sleep disorders in the
perioperative period are not uncommon. Preoperative anxiety can have adverse
effects on the sleep pattern of the patient undergoing surgery. Poor sleep
quality can lead to increased postoperative pain scores and increased length
of hospital stay.
Pharmacological methods for
alleviating anxiety and improving sleep quality can cause adverse effects
such as drowsiness and prolonged recovery when not administered in
appropriate doses. In neurosurgical patients, pharmacological methods of
anxiolysis can lead to excessive drowsiness and respiratory depression and
are thus generally not administered.
Oral Melatonin has various
physiological effects on the body especially on the circadian rhythm. The
onset of action is within 30-60 minutes and it has a duration of action of 4
to 10 hours. It induces regulation of sleep-wake rhythm in patients with
sleep disturbances. It also has many potential benefits such as oncostatic
effects, autonomic cardiovascular regulation, protection against
neuroinflammation and antioxidant effects. As it has potent sedative and
hypnotic effects, it is used as a premedication for anxiolysis in the
preoperative period.
Although the role of oral
melatonin premedication in patients undergoing surgery under local
anaesthesia and general anaesthesia has been well established through
previous research, its use as a premedicant in neurosurgical patients is less
studied. Hence, this study can prove to be beneficial in establishing the
role of oral melatonin premedication in neurosurgical patients undergoing
awake craniotomy. Thus, we will be studying the effect of oral melatonin premedication on patients satisfaction score, anxiety and sleep quality.
|
|