Melatonin vs Gabapentin for Post Trauma Surgery

A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05699876

Enrollment

Registered

2023-01-26

Start date

2023-01-15

Completion date

2023-11-30

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Preoperarative

Keywords

melatonin, gabapentin, preoperative anxiety

Brief 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. 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.

Interventions

DRUGMelatonin 6 MG

melatonin will be administered orally preoperatively as premedication

DRUGGabapentin

melatonin will be administered orally preoperatively as premedication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
preoperative anxiety	30 minutes after drug administration	evaluate the difference in the preoperative anxiety score(Numerical Rating Scale ) before and after drug administration

Secondary

Measure	Time frame	Description
inflammatory markers	before and 30 minutes after drug administrartion	o The serum cortisol and IL6 levels (biochemical markers of stress) intraoperatively and postoperatively
Sedation score	before and 30 minutes after drug administrartion	Sedation score based on Observer Assessment of Alertness/Sedation Scale (OAA/S) before and after drug administration
post operative analgesia	24 hours postoperative	o Total fentanyl consumption 24 hours post-surgery

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026