Melatonin vs Gabapentin for Post Trauma Surgery

January 24, 2023 updated by: Kelika Prakash, All India Institute of Medical Sciences, New Delhi

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin
Drug: Melatonin 6 MG
melatonin will be administered orally preoperatively as premedication
Active Comparator: Gabapentin
Drug: Gabapentin
melatonin will be administered orally preoperatively as premedication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes after drug administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIIMS Delhi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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