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Comparative Study of Hemodynamic Changes Caused by Diazepam and Midazolam During Third Molar Surgery

NCT02177955 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-06-30

No results posted yet for this study

Summary

Objective: The aim of the present study was to compare hemodynamic changes using 7.5 mg of midazolam and 10.0 mg of diazepam during the surgical removal of symmetrically positioned third molars.

Study design: A prospective, randomized, double-blind, clinical trial was carried out involving 120 patients divided in three groups: Group 1 (diazepam and placebo), Group 2 (midazolam and placebo) and Group 3 (diazepam and midazolam). Each subject underwent two surgeries on separate occasions under local anesthesia.

Conditions

Interventions

DRUG

7.5 mg Midazolam

7.5 mg midazolam 45 minutes before surgery

DRUG

10 mg diazepam

10 mg midazolam 45 minutes before surgery

Sponsors & Collaborators

  • University of Pernambuco

    collaborator OTHER

  • Jimmy Barbalho

    lead OTHER

Principal Investigators

  • Hécio H De Morais, PhD · University of Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-07-31
Completion
2012-09-30

Countries

  • Brazil

Study Locations

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Entities

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 NCT02177955 on ClinicalTrials.gov