| CTRI Number |
CTRI/2025/07/091965 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative study of effectiveness of two different drugs (alprazolam and melatonin) on the quality of sleep in patients posted for elective surgery |
|
Scientific Title of Study
|
A Comparative study of effects of melatonin and alprazolam on the quality of sleep in patients posted for elective surgery - prospective randomised control 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 |
Janet Jassica J |
| Designation |
Post graduate |
| Affiliation |
St. Johns Medical College and Hospital |
| Address |
Department of Anaesthesiology,Second Floor OT Complex, St.
Johns Medical College and Hospital, Bangalore-560034 Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
8220432477 |
| Fax |
|
| Email |
janetjassica1998@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vikram Shivappagoudar M |
| Designation |
Professor |
| Affiliation |
St. Johns Medical College and Hospital |
| Address |
Department of Anaesthesiology,Second Floor OT Complex, St.
Johns Medical College and Hospital, Bangalore-560034 Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
9731981665 |
| Fax |
|
| Email |
msvikram681@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vikram Shivappagoudar M |
| Designation |
Professor |
| Affiliation |
St. Johns Medical College and Hospital |
| Address |
Department of Anaesthesiology,Second Floor OT Complex, St.
Johns Medical College and Hospital, Bangalore-560034 Sarjapur -
Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala,
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
9731981665 |
| Fax |
|
| Email |
msvikram681@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns medical college and hospital, Koramangala, Bangalore-560034 |
|
|
Primary Sponsor
|
| Name |
Dr Janet Jassica J |
| Address |
Department of Anaesthesiology ,Second Floor OT Complex,St.
Johns Medical College and Hospital, Bangalore-560034 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Janet Jassica J |
St Johns medical college and hospital |
Department Of
Anaesthesiology,
Second floor OT
Complex, St Johns
medical college and
hospital.Koramangala,
Bangalore
KARNATAKA Bangalore KARNATAKA |
8220432477
janetjassica1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,St Johns Medical College Hospital |
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 |
| Intervention |
Medication |
Medication will be given once at night per orally on the previous day of surgery |
| Comparator Agent |
Tablet Alprazolam 0.25 mg |
Patients in group A will receive Tablet Alprazolam 0.25 mg orally once at 10pm night before their elective surgery. |
| Comparator Agent |
Tablet Melatonin 3mg |
Patients in group M will receive Tablet Melatonin 3mg at 10pm night once before their elective surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status Classes 1 and 2, posted for various elective surgeries. |
|
| ExclusionCriteria |
| Details |
Patients with OSA
Patients with h/o insomnia and on insomnia medication
Pregnant women
Patients with any mental illness
Patients on steroids and antipsychotics
Trauma patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) sleep onset
b) sleep duration
c) sleep quality
|
a) baseline before giving medication on the night before surgery and on the morning prior to surgery.
b) baseline before giving medication on the night before surgery and on the morning prior to surgery.
c) baseline before giving medication on the night before surgery and on the morning prior to surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pre operative anxiety |
baseline before giving medication on the night before surgery & on the morning prior to surgery.
|
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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)
|
15/08/2025 |
| 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="2" Months="0" 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
|
Introduction
Pre-operative sleep disturbances
can affect healthy patients who otherwise do not have chronic sleep issues or
medical conditions. These disturbances can be triggered by the stress and
anxiety associated with the anticipation of surgery, fear of anaesthesia and
concerns of the outcome of surgery, leading to difficulty falling asleep
or staying asleep. The unfamiliar hospital environment, if patients are
required to stay overnight, can worsen sleep disturbances. Alprazolam, a benzodiazepine
that acts by enhancing the effects of
gamma aminobutyric acid is used as a
pre anaesthetic medication, primarily due to its anxiolytic and sedative
properties. A common dose for preoperative anxiety is 0.25 mg to 0.5 mg of
alprazolam on the night before surgery. The dose depends on the patient age,
medical history, and the level of anxiety. Melatonin is a hormone that
plays a key role in regulating the sleep wake cycle. It is naturally produced
by the pineal gland in the brain in response to darkness, promoting sleepiness
and helping to regulate circadian rhythms. Beyond sleep regulation, melatonin
has mild anxiolytic effects, which can help alleviate pre operative anxiety.
The typical dose of melatonin for preanesthesia medication ranges from 0.5 mg
to 3 mg. Unlike benzodiazepines like midazolam or alprazolam, melatonin does
not carry the same risks of dependency or withdrawal, making it a safer option.
Primary
objective
To compare the effects of melatonin and
alprazolam on the quality of sleep in patients posted for elective surgery
Secondary
objective
To assess the pre operative anxiety in both
the groups State inclusion criteria
Patients aged 18 to 59 years with the American Society
of Anaesthesiologists physical status Classes 1 and 2, posted for various
elective surgeries.
State exclusion criteria
Patients with OSA
Patients with history of insomnia and on insomnia
medication
Pregnant women
Patients with any mental illness
Patients on steroids and antipsychotics Trauma patients Following written informed consent, they will be
randomised into one of the two groups, Alprazolam group A and Melatonin group M.
Randomisation will be done by the lot system. A baseline assessment of quality
of sleep and anxiety will be done on all patients using the GSQS and STAI 6. Patients in group A will
receive Tablet Alprazolam 0.25 mg orally and and patients of group M will
receive Tablet Melatonin 3mg at 10pm night before their elective surgery. Patients will be
instructed to refrain from the caffeinated drinks, screen time and follow their
routine sleep schedule. On the morning of the
surgery, the quality of sleep in the night before, will be assessed by the
Groningen Sleep Quality Scale GSQS and the anxiety levels will be assessed by
the State Trait Anxiety Inventory 6 STAI 6 scale. Patients with a GSQS
score of 0 to 2 will be considered to have had a good quality sleep, 3 to 5 as
with mild sleep disturbances, 6 to 9 as moderate sleep disturbances and 10 to
15 as severe sleep disturbances. Patients STAI 6 Anxiety
score, after reversing the positively worded items, summing the scores, and
standardization to 20 to 80 score, patient with score 20 to 39 will be
considered as Low anxiety, 40 to 59 as Moderate anxiety and 60 to 80 as High
anxiety
|