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Clinical Trials/CTRI/2023/01/049073
CTRI/2023/01/049073CompletedNot Applicable

A comparative study of melatonin and gabapentin in reducing preoperative anxiety

AIIMS New delhi1 site in 1 country70 target enrollmentStarted: January 18, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Difference in the change in VAS anxiety score

Study Overview

Brief Summary

Reductionin preoperative anxiety reduces postoperative pain, improves post surgeryrecovery and even leads to early discharge. In addition providing analgesiabefore the start of surgery(Preemptive analgesia) has been also been associatedwith reduced postoperative pain. Patients suffering from trauma have highstress levels making them it even more pertinent to tackle preoperative anxietyand pain. Through this project we intend to find the appropriate premedicationwhich reduces preoperative anxiety and thereby reduces postoperative pain andthus improves patient outcome.

ExpectedOutcome**:** It isexpected that melatonin will be superior to alprazolam and gabapentin inreducing preoperative anxiety as well as postoperative analgesic requirements.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •PAtients undergoing routine surgery after trauma ASA I and asa II patients.

Exclusion Criteria

  • •a)Patients for emergency surgeries b)Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels) c)Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication.

Outcomes

Primary Outcomes

Difference in the change in VAS anxiety score

Time Frame: Difference in the change in VAS anxiety score at 90 minutes after drug administration

Secondary Outcomes

  • Change in IL6 and serum cortisol levels(90 minutes post drug administration)

Investigators

Sponsor
AIIMS New delhi
Sponsor Class
Research institution

Study Sites (1)

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