跳至主要内容
临床试验/CTRI/2024/06/068590
CTRI/2024/06/068590尚未招募4 期

Comparative Study for the Efficacy of Sugammadex 1mg/kg and 2mg/kg for the Reversal of Neuromuscular blockade after Vecuronium for patients undergoing Elective surgery Under General Anaesthesia

Vijayanagar Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
1. The response to train - of - four stimulation just before sugammadex administration

研究概览

简要总结

After preoperative anaesthetic evaluation on the day of admission, the patients satisfying the criteria for selection will be explained about the procedure and consent will be obtained. Patient’s nil per oral status 6hrs for solids, 2 hours for liquids will be confirmed and shifted inside the operation theatre. The standard monitors will be connected and basal physiological parameters will be measured and mechanosensor based on kinemyography (TOF,GE healthcare) NM T will be attached to thumb and index finger of the patient and one brown electrode is placed on ulnar side 2cm below wrist joint and other white electrode is placed2cm below the 1st electrode. The mechanosensor measures the motion or the thumb with a piezoelectric sensor,which converts the physical motion to an electrical signal and quantifies the evoked mechanical response. The maximum twitch response will be noted. The patient will be given premedication with Inj Glycopyrrolate0.01 mg/kg, Inj Fentanyl 2mcg/kg, then preoxygenated with 100% oxygen for 3 minutes followed by Intravenous induction with Inj Propofol 2mg/kg and before administration of Inj Vecuronium 0. Img/kg. Repititve train-of-ratio(TOF)stimulation will be applied at ulnar nerve at the wrist every 15s until the end of anaesthesia or atleast until recovery of the TOF ratio().9. Body temperature will be maintained at ?35.0 0 C. Tracheal intubation will be performed after onset of complete blockade. Maintainence with Oxygen:Air/N20 according to the patient need and inj Vecuronium 0.020.03mg/kg administered as needed at reappearance of second twitch(T2) of the TOF if clinically required.At reappearance of T2 after last dose of vecuronium, Sugammadex I mg/kg in one group and 2m/kg in other group will be administered. After the TOF ratio >().9 tracheal extubation will be done. The assessments includes the level of consciousness (awake and oriented, arousable with minimal stimulation, or responsive only to tactile stimulation), muscle strength (ability to independently transfer from surgery table to bed, head tilting, and hand squeezing), and a 5-s head lift test. The respiratory frequency and pattern of the patient will be monitored and pulse oximetry will be performed in the PACU for at least 2 hours after the recovery of the TOF ratio to 0.9.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patients included under ASA grade 1 and 2.

排除标准

  • Renal dysfunction
  • Allergic to muscle relaxants
  • Pregnant females, breastfeeding females
  • History of chronic obstructive pulmonary disease.

结局指标

主要结局

1. The response to train - of - four stimulation just before sugammadex administration

时间窗: Muscle power,level of consciousness after extubation for 2minutes, 5minutes,10minutes,30minutes ,60minutes

次要结局

  • The incidence of recurrent paralysis during the postoperative monitoring period(15minutes, 30minutes,1hour after reversal)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kavya S Goudar

VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES BALLARI

研究点 (1)

Loading locations...

相似试验