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Clinical Trials/CTRI/2019/05/019329
CTRI/2019/05/019329Not yet recruitingNot Applicable

COMPARATIVE EFFECTIVENESS OF CLONIDINE WITH LIGNOCAINEVERSUS ADRENALINE WITH LIGNOCAINE IN MAXILLARY INFILTRATIONANESTHESIA FOR DENTAL EXTRACTION.

Dr Avadhut Phad1 site in 1 country30 target enrollmentStarted: March 6, 2019Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Onset of anesthesia Intensity of anesthesia

Study Overview

Brief Summary

The aim of the present clinical study is to evaluate whether an admixture of clonidine plus 2% lignocaine is an effective alternative to the epinephrine plus 2% lignocaine mixture in terms of Onset of anesthesia, Intensity of anesthesia, hemodynamic response, in patients undergoing bilateral removal of maxillary posterior teeth using maxillary infiltration anesthesia. Study Design: Split mouth double blind study. • Study setting: This study will be conducted in the Department of Oral & Maxillofacial Surgery.  • Study Population: 30 Healthy patients aged between 18-60 years requiring removal of bilateral maxillary posterior teeth reporting to department of oral & maxillofacial surgery will be included in the study. â€¢ Sampling Technique: Convenience sampling. • Selected patient will be divided into two groups and Extractions will be done in two different appointments .   The parameters to be evaluated for the study include: • Age & gender distribution: • Onset of anesthesia  • Intensity of anesthesia  • Hemodynamic parameters among the both groups: An observer, will be monitored all the patient for  o Heart Rate (HR), o Systolic Blood Pressure (SBP)  o Diastolic Blood Pressure (DBP).  o  Mean Arterial Pressure (MAP). • Initial measurements will be obtained prior to anesthesia. • Additional recordings will be made during  •  Administration of local anesthesia,  •  During the procedure,  •  5 min after administration of anesthesia,  •  10 min following completion of the procedure.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • This study will included patients between 18-60yr,
  • Teeth diagnosed with dental caries, teeth which could not be restored and patients who refused conservative management will be included in the study.
  • Patients requiring bilateral orthodontic extraction.
  • Patients willing to participate in the study.

Exclusion Criteria

  • Patients with complains of morbidities such as hypertension, diabetes mellitus, asthma, bleeding disorders.
  • Patient who have known allergies to any drug under study,
  • Pregnant women, nursing mothers and apprehensive patients will be excluded from the study.
  • Patients with impacted teeth will be excluded from the study.
  • Patients with the oro-facial space infection will be excluded from the study.

Outcomes

Primary Outcomes

Onset of anesthesia Intensity of anesthesia

Time Frame: 1.The onset of anesthesia will be investigated by probing with Moons probe every 30 sec. after withdrawal of needle until the probing does not induce pain sensation. | 2.Hemodynamic parameters will be continuously monitored in all patients to record heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure will be taken during administration of local anesthesia, 5 min after administration of anesthesia, during surgery and 10 min following completion of surgery.

Hemodynamic parameters among the both groups: An observer, will be monitored all the patient for

Time Frame: 1.The onset of anesthesia will be investigated by probing with Moons probe every 30 sec. after withdrawal of needle until the probing does not induce pain sensation. | 2.Hemodynamic parameters will be continuously monitored in all patients to record heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure will be taken during administration of local anesthesia, 5 min after administration of anesthesia, during surgery and 10 min following completion of surgery.

Systolic Blood Pressure (SBP)

Time Frame: 1.The onset of anesthesia will be investigated by probing with Moons probe every 30 sec. after withdrawal of needle until the probing does not induce pain sensation. | 2.Hemodynamic parameters will be continuously monitored in all patients to record heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure will be taken during administration of local anesthesia, 5 min after administration of anesthesia, during surgery and 10 min following completion of surgery.

Heart Rate (HR),

Time Frame: 1.The onset of anesthesia will be investigated by probing with Moons probe every 30 sec. after withdrawal of needle until the probing does not induce pain sensation. | 2.Hemodynamic parameters will be continuously monitored in all patients to record heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure will be taken during administration of local anesthesia, 5 min after administration of anesthesia, during surgery and 10 min following completion of surgery.

Diastolic Blood Pressure (DBP).

Time Frame: 1.The onset of anesthesia will be investigated by probing with Moons probe every 30 sec. after withdrawal of needle until the probing does not induce pain sensation. | 2.Hemodynamic parameters will be continuously monitored in all patients to record heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure will be taken during administration of local anesthesia, 5 min after administration of anesthesia, during surgery and 10 min following completion of surgery.

Mean Arterial Pressure (MAP).

Time Frame: 1.The onset of anesthesia will be investigated by probing with Moons probe every 30 sec. after withdrawal of needle until the probing does not induce pain sensation. | 2.Hemodynamic parameters will be continuously monitored in all patients to record heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure will be taken during administration of local anesthesia, 5 min after administration of anesthesia, during surgery and 10 min following completion of surgery.

Secondary Outcomes

  • Age & gender distribution:(Onset of anesthesia)

Investigators

Sponsor
Dr Avadhut Phad
Sponsor Class
Other [PG Student]

Study Sites (1)

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