| CTRI Number |
CTRI/2025/12/099857 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study comparing melatonin and pregabalin tablets to control blood pressure and heart rate during anaesthesia for head and neck surgery |
|
Scientific Title of Study
|
A Prospective Randomized Comparative Study For Evaluation Of Clinical Efficacy Of Oral Melatonin VS Oral Pregabalin Used As Premedication For Attenuation Of Hemodynamic Response To Laryngoscopy And Endotracheal Intubation In Patients
Undergoing Head And Neck Surgery Under General Anaesthesia. |
| 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 Singh |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8279893189 |
| Fax |
|
| Email |
Charu.dr2025@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9520531558 |
| Fax |
|
| Email |
ravi.agrawalravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Charu Singh |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8279893189 |
| Fax |
|
| Email |
Charu.dr2025@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia LLRM medical college meerut 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM medical College |
| Address |
Department of Anaesthesia, LLRM medical college, meerut, uttar pradesh 250004 |
| Type of Sponsor |
Government 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 Charu Singh |
LLRM medical college meerut |
Department of anaesthesia LLRM medical college meerut uttar pradesh Meerut UTTAR PRADESH
Meerut
UTTAR PRADESH |
8279893189
charu.dr2025@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee LLRM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H719||Unspecified cholesteatoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral melatonin 6mg
oral pregabalin 150mg
oral placebo given to patients 2hours before surgery. |
Ninety patients are randomly allocated into three groups to receive oral melatonin 6mg ,oral pregabalin 150mg or placebo 2 hours before induction of anaesthesia. Hemodynamic changes to larngoscopy and intubations are observed. |
| Intervention |
Oral melatonin, Oral Pregabalin and oral placebo given to patients 2hours before surgery. |
Ninety patients are randomly allocated into three groups to receive oral melatonin 6 mg, oral pregabalin 150 mg, or placebo 2 hours before induction of anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.(ASA) Grade I and II
2.Age: from18 to 60 years.
3.Patients of either sex
4.Patients planned for Elective surgery receiving general anesthesia requiring tracheal intubation.
5.Surgery duration: 30 minutes to 2 hrs
|
|
| ExclusionCriteria |
| Details |
1. Patient Refusal
2. Patients with difficult airway MP grade 3 and 4.
3.Patient on Antidepressant and Anxiolytics.
4. Patients with coexisting systemic illness like respiratory and cardiovascular diseases, increased intracranial pressure.
5. Increased risk for preoperative aspiration of gastric contents (patients nil per oral not less than 6 hrs.). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Attenuation of hemodynamic response to laryngoscopy and endotracheal intubation by oral melatonin and oral pregabalin used as premedication.
2. Requirement of induction dose of injection propofol.
|
Till 2 hours postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out if any adverse event occurs in patients receiving oral melatonin.
2. To find out if any adverse event occurs in patients receiving oral pregabalin.
3. Post-operative recovery profile. |
Till 2 hour postoperatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/01/2026 |
| 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="3"
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
|
This is prospective, randomized, double-blind interventional study to compare the efficacy of oral melatonin and oral pregabalin as premedication for attenuating the hemodynamic response to laryngoscopy and endotracheal intubation. Ninety ASA I–II patients undergoing elective head and neck surgery under general anesthesia are randomly allocated to receive melatonin, pregabalin, or placebo two hours before surgery. Hemodynamic parameters, anesthetic drug requirements, and recovery profile is assessed and compared among the groups. The study aims to identify an effective and safe premedication for blunting sympathoadrenal responses during airway manipulation.
|