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Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

NCT01486615 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-10-05

Study results available
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Summary

Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and thus paradoxically increases episodes of arousal during sleep and thus causes restlessness and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the perception of sound sleep in the perioperative period.

Methods: Eighty patients (ASA 1\&2) with anxiety VAS ≥ 2 posted for general anaesthesia will be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of 0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P), approximately 90 minutes before surgery.

Conditions

Interventions

DRUG

meloset (melatonin)

3 mg melatonin tablet 1-2 hour prior surgery

DRUG

stresnil ( melatonin and alprazolam)

3 mg melatonin and 0.5 mg alprazolam 1-2 hr before anesthesia

DRUG

(alprax) alprazolam

0.5 mg alprazolam

DRUG

placebo

similar looking placebo tablet

Sponsors & Collaborators

  • B.P. Koirala Institute of Health Sciences

    lead OTHER

Principal Investigators

  • Krishna Pokharel, MD · B.P. Koirala Institute of Health Sciences

  • Balkrishna Bhattarai, MD · B.P. Koirala Institute of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Nepal

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486615 on ClinicalTrials.gov