Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
This study has been completed.
Sponsor:
Federal University of the Valleys of Jequitinhonha and Mucuri
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Marcos Luciano Pimenta Pinheiro, Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier:
NCT01612130
First received: June 1, 2012
Last updated: June 5, 2012
Last verified: June 2012
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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: Double Blind (Subject, 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 Federal University of the Valleys of Jequitinhonha and Mucuri:
Primary Outcome Measures:
- Signs and symptoms of anxiety [ Time Frame: 1 day (during dental appointment) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Level of blood oxygen saturation 30 minutes after drug administration and throughout the surgical procedure.
- Side effects of drugs [ Time Frame: 1 week ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | June 1, 2012 |
| Last Updated: | June 5, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013