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Melatonin vs Gabapentin for Post Trauma Surgery

A

All India Institute Of Medical Science (AIIMS)

Status

Enrolling

Conditions

Anxiety, Preoperarative

Treatments

Drug: Melatonin 6 MG
Drug: Gabapentin

Study type

Interventional

Funder types

Other

Identifiers

NCT05699876
AIIMS Delhi

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Melatonin
Experimental group
Treatment:
Drug: Melatonin 6 MG
Gabapentin
Active Comparator group
Treatment:
Drug: Gabapentin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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