NCT02177955

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 anxiety

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

1.5 years

First QC Date

June 21, 2014

Last Update Submit

June 26, 2014

Conditions

Anxiety

Keywords

Third MolarAnty-anxiety drugshemodynamicBenzodiazepines

Outcome Measures

Primary Outcomes (7)

  • Changes from baseline in systolic blood pressure until the end of surgery

    baseline, 2 minutes, 7 minutes, 12 minutes, end of surgery.

  • Changes from baseline in diastolic blood pressure until the end of surgery

    Baseline, 2 minutes, 7 minutes, 12 minutes, end of surgery

  • Changes from baseline in mean blood pressure until the end of surgery

    Baseline, 2 minutes, 7 minutes, 12 minutes, end of surgery

  • Changes from baseline in heart rate until the end of surgery

    Baseline, 2 minutes, 7 minutes, 12 minutes, end of surgery

  • Changes from baseline in rate pressure product until the end of surgery

    The rate pressure is the product of the multiplication of systolic blood pressure by heart rate

    Baseline, 2 minutes, 7 minutes, 12 minutes, end of surgery

  • Changes from baseline in oxygen saturation until the end of surgery

    Baseline, 2 minutes, 7 minutes, 12 minutes, end of surgery

  • Change from baseline in pressure rate quotient until the end of surgery

    Pressure rate quotient is calculated by dividing mean blood pressure by heart rate

    Baseline, 2 minutes, 7 minutes, 12 minutes, end of surgery

Study Arms (2)

midazolan

PLACEBO COMPARATOR

7.5 mg midazolan 45 minutes before the surgery

Drug: 7.5 mg Midazolam

diazepam

PLACEBO COMPARATOR

10 mg diazepam 45 minutes before the surgery

Drug: 10 mg diazepam

Interventions

7.5 mg MidazolamDRUG

7.5 mg midazolam 45 minutes before surgery

midazolan
10 mg diazepamDRUG

10 mg midazolam 45 minutes before surgery

diazepam

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry of Pernambuco

Recife, Pernambuco, 54756220, Brazil

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Interventions

MidazolamDiazepam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzodiazepinones

Study Officials

  • Hécio H De Morais, PhD

    University of Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DDs

Study Record Dates

First Submitted

June 21, 2014

First Posted

June 30, 2014

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

BR(1)