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Melatonin vs Gabapentin for Post Trauma Surgery

Not Applicable
Recruiting
Conditions
Anxiety, Preoperarative
Interventions
Registration Number
NCT05699876
Lead Sponsor
All India Institute of Medical Sciences, New Delhi
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MelatoninMelatonin 6 MG-
GabapentinGabapentin-
Primary Outcome Measures
NameTimeMethod
preoperative anxiety30 minutes after drug administration

evaluate the difference in the preoperative anxiety score(Numerical Rating Scale ) before and after drug administration

Secondary Outcome Measures
NameTimeMethod
post operative analgesia24 hours postoperative

o Total fentanyl consumption 24 hours post-surgery

inflammatory markersbefore and 30 minutes after drug administrartion

o The serum cortisol and IL6 levels (biochemical markers of stress) intraoperatively and postoperatively

Sedation scorebefore and 30 minutes after drug administrartion

Sedation score based on Observer Assessment of Alertness/Sedation Scale (OAA/S) before and after drug administration

Trial Locations

Locations (1)

Aiims

🇮🇳

New Delhi, Delhi, India

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