跳至主要内容
临床试验/CTRI/2021/05/033305
CTRI/2021/05/033305已完成不适用

EFFICACY OF DIFFERENT DOSES OF INTRANASAL DEXMEDETOMIDINE ON HEMODYNAMIC RESPONSE TO INTUBATION - A PROSPECTIVE DOUBLE BLINDED CONTROLLED TRIAL

SUJATHA1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年5月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
TO COMPARE THE SYSTOLIC BLOOD PRESSURE, DIASTOLIC BLOOD PRESSURE ,MEAN ARTERIAL PRESSURE

研究概览

简要总结

Institutional ethical committee approval will be obtained.

Patients will be enrolled in the study after obtaining informed consent.

Randomization is done by computer generated random number table to either undergo 0.7 mcg/kg intranasal dexmedetomidine or 1 mcg/kg intranasal dexmedetomidine or intravenous lignocaine 1.5 mg /kg.

The patient and the person administering the drug, performing laryngoscopy and monitoring the vital parameters will be blinded to the group assignment. Blinding is ensured by asking a person who is not involved in the study to load the drug as per the allocated groups.

Preoperatively Nil per oral orders will be followed as per guidelines.

On the day of surgery, the patient will be shifted to perioperative area 1 hour before the surgery. The standard monitors will be attached and baseline parameters will be recorded using pulse oximetry, non invasive blood pressure. IV Ringer lactate solution will be administered as maintenance fluid ( 80 ml /hr ) through the 18 G peripheral venous cannula.

Group A will be receiving intranasal dexmedetomidine 0.7mcg/kg, administered by an atomiser 30 min before induction. 10 ml of Normal saline will be administered intravenously to group A patients 90 seconds before intubation.

Group B patients will be receiving intranasal dexmedetomidine 1mcg/kg , administered by an atomiser 30 min before induction .10 ml of Normal saline will be administered intravenously to group B patients 90 seconds before intubation.

Group C patients will be receiving intravenous lignocaine 1.5 mg/kg, administered 90 sec before intubation .1 ml of normal saline will be administered intranasally 30 min before induction.

The delivery of dexmedetomidine is done with an atomiser. An equal volume of drug will be given via 2 nostrils. Atomisation will be performed with the participant sitting up with slight backward  head tilt as this allows optimal spread and absorption of atomised solutions.

 In the preoperative holding area , the vital parameters like HR, SBP, DBP, MAP, Ramsay sedation score will be noted .

After shifting the patient to the operative room, the general anesthesia techniques will be standardised to three groups. After preoxygenation with 100%oxygen for 3 minutes, the patient will be induced with Iv fentanyl 2 mcg/kg ,Iv propofol 2 mg/kg and Iv cisatracurium 0.2 mg/kg. Intubation will be done by DL scopy after 90 seconds of cis atracurium administration. Duration of laryngoscopy – time of insertion of  laryngoscope till the appearance of ETCO2 trace will be noted. Patients will be excluded if there is more than two attempts of laryngoscopy. Hemodynamic parameters will be measured at preinduction, preintubation ,postintubation every 3 min for over 10 mins .Anesthesia will be maintained with 50%oxygen-air mixture and cisatracurium will be repeated as and when necessary. The hemodynamic parameters will be monitored throughout the operative period. Episodes of hypotension (decrease in MAP of 20% from baseline) , bradycardia (HR < 50 bpm ) and hypoxia (spo2 < 90% ) within the study period will be noted and treated accordingly . After completion of surgery ,the patients will be reversed with IV neostigmine 0.05 mg/kg and IV glycopyrolate 0.01mg /kg

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • 18 to 60 yrs elective surgery under general anesthesia.

排除标准

  • 1.patient refusal 2.allergy to dexmedetomidine 3.significant respiratory and cardiac disease 4.predicted difficult airway patient with nasal polyps,ulcers.

结局指标

主要结局

TO COMPARE THE SYSTOLIC BLOOD PRESSURE, DIASTOLIC BLOOD PRESSURE ,MEAN ARTERIAL PRESSURE

时间窗: 0 min,30 min,preinduction,preintubation,postinduction for over 10 min

次要结局

  • TO COMPARE THE SEDATION SCORE AND OTHER ADVERSE EVENTS(3 HRS)

研究者

发起方
SUJATHA
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验