| CTRI Number |
CTRI/2022/08/044912 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
12/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effects of oral melatonin and alprazolam as preoperative medicine and their effects on post operative recovery in patients undergoing ear surgery |
|
Scientific Title of Study
|
Comparative evaluation of effects of oral melatonin and oral alprazolam as premedication and their effects on post operative recovery characteristics in patients undergoing tympanoplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nupoor |
| Designation |
First Year Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, 2nd Floor, Sharda Hospital, Knowledge Park 3, Greater Noida
Sharda Hospital, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717912144 |
| Fax |
|
| Email |
nupoor.1@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsh Vardhan |
| Designation |
Professor |
| Affiliation |
School of Medical Science and Research |
| Address |
Department of Anaesthesiology, Sharda Hospital, Plot No. 32, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
|
| Fax |
|
| Email |
harsh.vardhan1@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Vardhan |
| Designation |
Professor |
| Affiliation |
School of Medical Science and Research |
| Address |
Department of Anaesthesiology, Sharda Hospital, Plot No. 32, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
|
| Fax |
|
| Email |
harsh.vardhan1@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| Sharda Hospital, Knowledge Park 3, Greater Noida, UP |
|
|
Primary Sponsor
|
| Name |
Sharda Hospital |
| Address |
Plot No. 32, Knowledge Park 3, Greater Noida |
| 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 |
| Nupoor |
Sharda Hospital, School of Medical science and Research |
Department of Anaesthesiology, 2nd floor, B block, Sharda Hospital, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9717912144
nupoor.1@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alprazolam |
Tab Alprazolam 0.5mg to be given orally to patients 2 hours prior to surgery |
| Intervention |
Melatonin |
Tab Melatonin 6mg to be given orally to patients 2 hours prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing tympanoplasty surgeries under general anaesthesia
2. ASA class I and II |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study
2. Patients receiving steroids, analgesics, antiemetic, sedatives and antipsychotics.
3. Patients having history of endocrine, cardiovascular, renal or CNS disease.
4. Patients allergic to study drugs.
5. BMI > 30 kg m-2
6. Patient having chronic pain and any mental illness
7. Pregnant patients
8. Patients with inability to read and write basic alphabets and numbers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of melatonin and alprazolam on preoperative anxiety. |
2 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the effects of melatonin and alprazolam on:
(a) Pre-operative sedation
(b) Pre-operative cognition
2. To compare the effects of melatonin and alprazolam on:
(a) Post-operative sedation
(b) Post-operative anxiety
(c) Post-operative cognition
3. To compare post operative pain in the two groups |
2 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/09/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premedication has some important goals like relief of anxiety, sedation and analgesia. Preoperative anxiety is commonly experienced by the patients who are admitted to hospital for any surgery which can be described as an unpleasant state of tension or uneasiness that results from a patient’s doubts or fears about the surgery and anaesthesia. It increases patient’s catecholamine secretions which may lead to hypertension, tachycardia, and arrhythmias. Anxiety in surgical patients increases the need of anaesthetic drugs. Benzodiazepines (midazolam and alprazolam) are most commonly used as a premedication to alleviate perioperative anxiety and to produce amnesia and sedation; however, they may impair cognitive and psychomotor performance. Alprazolam (triazolobenzodiazepine) is a short-acting drug which has anxiolytic, sedative, hypnotic, anticonvulsant, and amnesic properties but may cause psychomotor impairment. Melatonin (N-acetyl-5-methoxytryptamine) is an endogenous neurohormone secreted by the pineal gland. It has unique property of producing anxiolysis with no impairment of cognitive and psychomotor function that is highly desirable in routine perioperative care when given orally as a premedication. It has inhibitory action on central nervous system. It also has sedative, hypnotic, analgesic, anti-inflammatory, antioxidative, and chronobiotic effects. The melatonin has been reported to be used as a premedication in a dose range of 3–15 mg given orally or sublingually 50–90 min preoperatively. The peak effect of oral melatonin ranges from 60 to 150 min. Hence, it is hypothesized that melatonin (6 mg) when given orally as a premedication 120 min before the induction of anaesthesia would provide adequate anxiolysis and arousable sedation with no effect on cognitive and psychomotor function along with stable hemodynamics and minimal side effects. In this study, we plan to compare the effects of oral melatonin and alprazolam as a premedication on various parameters including anxiety, sedation, cognition, psychomotor function and analgesia. |