Melatonin vs Gabapentin for Post Trauma Surgery | NCT05699876

Studies
Melatonin vs Gabapentin for Post Trauma Surgery

NCT05699876

Sponsor

All India Institute of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 26, 2023Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Anxiety, Preoperarative

Interventions

Melatonin 6 MG
Gabapentin

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2023Estimated

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Nov 30, 2023Estimated

First Submitted Date

Jan 12, 2023

First Submission Date that Met QC Criteria

Jan 24, 2023

First Posted Date

Jan 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2023

Last Update Posted Date

Jan 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kelika Prakash, Assistant Professor, All India Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

All India Institute of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Melatonin	Experimental		Drug: Melatonin 6 MG
Gabapentin	Active Comparator		Drug: Gabapentin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin 6 MG	Drug	melatonin will be administered orally preoperatively as premedication	Melatonin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
inflammatory markers	o The serum cortisol and IL6 levels (biochemical markers of stress) intraoperatively and postoperatively	before and 30 minutes after drug administrartion
Sedation score

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aiims	Recruiting	New Delhi	National Capital Territory of Delhi	110029	India

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin
D000077206	Gabapentin

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided