跳至主要内容
临床试验/CTRI/2023/07/055886
CTRI/2023/07/055886尚未招募4 期

Comparison of ketamine, dexmedetomidine, ketodex in prevention of emergence agitation in adults undergoing nasal surgery

John Mammen1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年10月8日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To compare the level of emergence agitation in patients receiving ketamine, dexmedetomidine

研究概览

简要总结

Emergence agitation is a common side effect seen following nasal surgeries. Emergence agitation involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anaesthesia and can cause injury to patients and unwanted accidents in the operation theatre and post anaesthesia care unit. Various drugs have been used to decrease the incidence of emergence agitation following nasal surgeries.We are comparing the effects of three drugs ketamine, dexmedetomidine and a combination of ketamine and dexmedetomidine ie; ketodex which are routinely used to ameliorate or prevent emergence agitation, by comparison of recovery characteristics including extubation and Recovery time( Time in minutes from when inhalation agent is discontinued,to response to first verbal command);Level of agitation assessed by Riker Sedation Agitation Scale,level of painwill be assessed by Numeric pain rating scale;Hemodynamic parameters will be compared at regular intervals  at post operative anaesthesia care unit;Post operative nausea vomiting will be assessed by 4 Point Post operative nausea and vomiting scale ;and Discharge time at arrival to post-anaesthesia care unite (PACU) to discharge to the ward according to modified Aldrete score, patients having Aldrete score of 9 or higher will be discharged to the ward.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex scheduled for elective nasal surgeries under general anaesthesia -American society of Anesthesiologists physical status I,II.

排除标准

  • Patients with altered mental status Patients on psychoactive/analgesics/ Beta agonist drugs Pregnant women Patient with known allergy or hypersensitivity to the drugs used in the study Patients with anticipated difficult airway.

结局指标

主要结局

To compare the level of emergence agitation in patients receiving ketamine, dexmedetomidine

时间窗: Level of agitation assessed by Riker Sedation Agitation scale, At recovery & at admission to PACU. hemodynamic parameters, postoperative nausea vomiting and pain scores every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit

and ketodex atrecovery from general anaesthesia & admission to post anaesthesia care unit, Hemodynamic parameters, post operative nausea vomiting, pain score

时间窗: Level of agitation assessed by Riker Sedation Agitation scale, At recovery & at admission to PACU. hemodynamic parameters, postoperative nausea vomiting and pain scores every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit

次要结局

  • Hemodynamic parameters(every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit)
  • Recovery time(Time in minutes from when sevoflurane is discontinued,to response to first verbal command)
  • Level of pain(Will be assessed by Numeric pain rating scale at admission to postoperative anaesthesia care unit & at discharge from postoperative anaesthesia care unit.)
  • Discharge time in minutes(The time from arrival to post-anaesthesia care unite (PACU) to discharge to the ward according to modified Aldrete score)
  • Extubation time(Time from discontinuing sevoflurane to extubation.)
  • Post operative nausea vomiting:(assessed by 4 Point Post operative nausea & vomiting scale at admission to post operative care unit and at discharge from post operative care unit)

研究者

发起方
John Mammen
申办方类型
Other [self]

研究点 (1)

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