Melatonin vs Gabapentin for Post Trauma Surgery

NCT ID: NCT05699876

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety, Preoperarative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Melatonin

Group Type EXPERIMENTAL

Melatonin 6 MG

Intervention Type DRUG

melatonin will be administered orally preoperatively as premedication

Gabapentin

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

melatonin will be administered orally preoperatively as premedication

Interventions

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Melatonin 6 MG

melatonin will be administered orally preoperatively as premedication

Intervention Type DRUG

Gabapentin

melatonin will be administered orally preoperatively as premedication

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Kelika Prakash

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aiims

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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member secretary

Role: primary

91-11-265904579

Other Identifiers

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AIIMS Delhi

Identifier Type: -

Identifier Source: org_study_id

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