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Trial record 2 of 11 for:    valerian | Completed Studies

Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612130
First Posted: June 5, 2012
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Marcos Luciano Pimenta Pinheiro, Federal University of the Valleys of Jequitinhonha and Mucuri
  Purpose
The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery.

Condition Intervention
Dental Anxiety Blood Pressure Heart Rate Drug: 100 mg of Valeriana officinalis L Drug: Placebo 100mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Valeriana Officinalis L. for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery: A Randomized, Double-Blind, Placebo-Controlled Crossover Study

Resource links provided by NLM:


Further study details as provided by Marcos Luciano Pimenta Pinheiro, Federal University of the Valleys of Jequitinhonha and Mucuri:

Primary Outcome Measures:
  • Signs and symptoms of anxiety [ Time Frame: 1 day (during dental appointment) ]
    During each surgery, the researcher and surgeon observed the manifestation of signs and symptoms associated to anxiety (restlessness/agitation/nervous ticks, paleness, excessive perspiration, tingling sensation in hands, feet or lips, change in breathing rhythm or depth). In the presence of one or more of these signs and symptoms, the patient was classified as anxious. If there was no manifestation of anxiety, the patient was classified as calm or relaxed

  • assessment of the blood pressure [ Time Frame: 1 day (during dental appointment) ]
    The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery.

  • Assesment of heart rate [ Time Frame: 1 day (during dental appointment) ]
    The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.


Secondary Outcome Measures:
  • Oxygen saturation [ Time Frame: 1 day (During dental appointment) ]
    Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.

  • Side effects of drugs [ Time Frame: 1 week ]
    Evaluation of the incidence of side effects of drugs used were informed by the patient after de drug administration until one week of postoperative period.


Enrollment: 20
Study Start Date: March 2003
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valeriana officinalis L (100mg)
100 mg of Valeriana officinalis L. (Valerian)
Drug: 100 mg of Valeriana officinalis L
A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures
Other Name: Valerian
Placebo Comparator: Placebo (100 mg)
Placebo 100mg
Drug: Placebo 100mg
A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures

Detailed Description:
Evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during third molar surgery. Study design: A single oral dose of either valerian (100 mg) or placebo was randomly administered one hour before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed through questionnaires, physiological parameters (blood pressure and heart rate) and the observation of signs.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell & Gregory classification

Exclusion Criteria:

  • Use of any type of medication in the 15 days prior to the onset of the study; history of hypersensitivity to the drugs, substances or materials employed in the experiment; pregnancy or lactation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612130


Locations
Brazil
Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
Federal University of the Valleys of Jequitinhonha and Mucuri
University of Campinas, Brazil
Investigators
Principal Investigator: Marcos Pinheiro, PhD Federal University of the Valleys of Jequitinhonha and Mucuri
  More Information

Responsible Party: Marcos Luciano Pimenta Pinheiro, Professor of Pharmacology and Therapeutics, Department of Basic Science, Biologic and Health Sciences Faculty, Federal University of Vales do Jequitinhonha e Mucuri - UFVJM, Diamantina, Minas Gerais, Brazil., Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier: NCT01612130     History of Changes
Other Study ID Numbers: 098/2002
First Submitted: June 1, 2012
First Posted: June 5, 2012
Last Update Posted: June 6, 2012
Last Verified: June 2012