Anxiety, PreoperarativeNCT05699876
Melatonin vs Gabapentin for Post Trauma Surgery
A study testing Melatonin 6 MG and Gabapentin in people with Anxiety, Preoperarative, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Preoperarative
- What is being tested?
- Melatonin 6 MG and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: Patients will be recruited if they satisfy the following inclusion criteria:
- Age 18-65 years,
- ASA score I-II,
- Scheduled either for non-emergency surgery after trauma and
- Presumptive duration of operation not exceeding 3 hours.
Exclusion criteria: The following patients will be excluded from the study:
- Patients for emergency surgeries
- Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels)
- Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication
- Patients who have come for a repeat surgery and have already been included once in the study
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Aiims
New Delhi, National Capital Territory of Delhi, 110029
member secretary, 91-11-265904579, ethicscommitteeaiims@aiims.ac.in
About this study
Official title: A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma
This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. It is now being explored as a preoperative medication.
- Conditions
- Anxiety, Preoperarative
- Being tested
- Melatonin 6 MG, Gabapentin
- Keywords
- melatonin, gabapentin, preoperative anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 6 MGDrug
melatonin will be administered orally preoperatively as premedication
GabapentinDrug
melatonin will be administered orally preoperatively as premedication
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Drug: Melatonin 6 MG |
| Gabapentin | Active comparator | Not described Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative anxiety
evaluate the difference in the preoperative anxiety score(Numerical Rating Scale ) before and after drug administration
Measured: 30 minutes after drug administration
Secondary outcomes (3)
inflammatory markers
- The serum cortisol and IL6 levels (biochemical markers of stress) intraoperatively and postoperatively
Measured: before and 30 minutes after drug administrartion
Sedation score
Sedation score based on Observer Assessment of Alertness/Sedation Scale (OAA/S) before and after drug administration
Measured: before and 30 minutes after drug administrartion
post operative analgesia
- Total fentanyl consumption 24 hours post-surgery
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, PreoperarativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelika Prakash, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699876
- Sponsor's protocol ID
- AIIMS Delhi
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma
- ClinicalTrials.gov ID
- NCT05699876
- Acronym / sponsor ID
- AIIMS Delhi
- Conditions
- Anxiety, Preoperarative
- Keywords
- melatonin, gabapentin, preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. It is now being explored as a preoperative medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatonin 6 MG |
| Gabapentin | Active comparator | Drug: Gabapentin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 6 MGmelatonin will be administered orally preoperatively as premedication | Drug | Melatonin |
| Gabapentinmelatonin will be administered orally preoperatively as premedication | Drug | Gabapentin |
Primary outcome
preoperative anxiety
Time frame: 30 minutes after drug administration
evaluate the difference in the preoperative anxiety score(Numerical Rating Scale ) before and after drug administration
3 secondary outcomes
inflammatory markers
Time frame: before and 30 minutes after drug administrartion
Sedation score
Time frame: before and 30 minutes after drug administrartion
post operative analgesia
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 6 MG and Gabapentin in people with Anxiety, Preoperarative, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative anxiety (time frame: 30 minutes after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.