NCT05699876

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 12, 2023

Last Update Submit

January 24, 2023

Conditions

Anxiety, Preoperarative

Keywords

melatoningabapentinpreoperative anxiety

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • inflammatory markers

    before and 30 minutes after drug administrartion

  • Sedation score

    before and 30 minutes after drug administrartion

  • post operative analgesia

    24 hours postoperative

Study Arms (2)

Melatonin

EXPERIMENTAL
Drug: Melatonin 6 MG

Gabapentin

ACTIVE COMPARATOR
Drug: Gabapentin

Interventions

Melatonin 6 MGDRUG

melatonin will be administered orally preoperatively as premedication

Melatonin
GabapentinDRUG

melatonin will be administered orally preoperatively as premedication

Gabapentin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aiims

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

MelatoninGabapentin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 26, 2023

Study Start

January 15, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

IN(1)