FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
AIIMS, New Delhi 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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. 

 
Close