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临床试验/CTRI/2019/05/019329
CTRI/2019/05/019329尚未招募不适用

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

Dr Avadhut Phad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年3月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Onset of anesthesia Intensity of anesthesia

研究概览

简要总结

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.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Onset of anesthesia Intensity of anesthesia

时间窗: 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

时间窗: 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)

时间窗: 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),

时间窗: 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).

时间窗: 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).

时间窗: 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.

次要结局

  • Age & gender distribution:(Onset of anesthesia)

研究者

发起方
Dr Avadhut Phad
申办方类型
Other [PG Student]

研究点 (1)

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