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临床试验/CTRI/2021/07/035181
CTRI/2021/07/035181已完成3 期

“Comparative evaluation of intranasal DEXMEDETOMIDINE spray versus intranasal NORMAL SALINE spray in patients undergoing transalveolar extractions for anxiety reduction – A RANDOMISED CONTROL STUDYâ€

DrMrudulaRavindra Mulay Self1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月8日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
This study will enable us to whether intranasal dexmedetomidine spray will provide better anxiety control and sedation or not in patients undergoing transalveolar extractions under local anesthesia with adrenaline.

研究概览

简要总结

The Transalveolar extractions are  one of the most common procedures performed in the field of oral and maxillofacial surgery. Dexmedetomidine is an alpha 2 - adrenoceptor agonist with dose-dependent alpha 2 adrenoceptor selectivity. It is a useful sedative agent that possesses analgesic properties, hemodynamic stability.Intranasal sedation is a non-invasive way of drug administration, which is safe and is well tolerated by children as well as adults . It also saves the fearful patient from receiving more injections.Pre-operative anxiety and discomfort are inevitable consequences in absence of preoperative sedation in patient undergoing transalveolar extractions. An ideal pre-medication allays apprehension in minds of patients and achieves a calm, sedated patient for smooth induction of anesthesia, hassle free transalveolar extractions  and rapid recovery in post-operative period.This study has been planned and will be conducted to find out the additional effectiveness and anxiety control  if any of dexmedetomidine nasal spray in transalveolar extractions of adult patients This information can be used to modify the Protocols as required.objectives are to evaluate and compare the anxiety level, sedation status and pain experience of the patient following intranasal dexmedetomidine spray and intranasal saline spray as a placebo effect during transalveolar extractions.and To evaluate and compare blood pressure, oxygen saturation and pulse rate following intranasal dexmedetomidine spray and intranasal saline spray as a placebo effect during transalveolar extractions.Patients under the study received  1.5mcg/kg of dexmedetomidine by intranasal spray prior to local anaesthesia for A group and intranasal normal saline spray for group B as control group as placebo effect.Double  blinding will be done at the level of the patient and principal investigator . He/ She will not be knowing which group they belong for achieving placebo effect. Follow Standard procedure for transalveolar extractions.During the procedure the oxygen saturation levels, pulse rate, blood pressure, of the patient was recorded immediately after the injection of local anesthesia and every 15 minutes from then till the end of the procedure.The sedation score was assessed using Ramsay’s Sedation Scale by the operating surgeon every 15 minutes after local anesthesia was given Pain experience was recorded with the help of the visual analogue scale every 15 minutes after injection of local anesthesia. The values were then tabulated and results were derived.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • 1.The participants with carious tooth / impacted tooth which needs to be removed by transalveolar method.
  • 2.Participants above age group of 18 and below the age of
  • 3.Participants of both the genders will be included.
  • 4.Participant who are physically and medically fit for the surgery.
  • 5.Patients undergoing transalveolar extractions and willing to participate in the study (with informed consent).

排除标准

  • 1.Medically compromised patients with extremes of ages.
  • 2.Patients not willing for the study 3.Patients with allergic rhinitis, breathing disorders and running nose.
  • 4.Patients allergic to dexmedetomidine.

结局指标

主要结局

This study will enable us to whether intranasal dexmedetomidine spray will provide better anxiety control and sedation or not in patients undergoing transalveolar extractions under local anesthesia with adrenaline.

时间窗: Baseline | (15min before surgery)0 Minutes | (Immediately After spray)15 Minutes | (Immediately After Injecting LA) | 30 Minutes45 Minutes

次要结局

  • evaluate and compare the anxiety level, sedation status of the patient following intranasal dexmedetomidine spray and intranasal saline spray as a placebo effect during transalveolar extractions.(Baseline)

研究者

发起方
DrMrudulaRavindra Mulay Self
申办方类型
Other [self]

研究点 (1)

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